364 Regulatory Analyst jobs in India

Regulatory Analyst

Pune, Maharashtra Confidential

Posted today

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Job Description

  • Product Data Mining from regulatory data tools.
  • Engaging with IT to backfill product data into ERP systems.
  • Customer Support on regulatory document requests.
  • Vendor engagement to obtain regulatory documents and data.
  • Ongoing regulatory data analysis and tracking.
  • Analysis of materials properties and compliance status.
  • Support part / material sampling and testing process.
  • Internal global stakeholder engagement in a regulatory support function as needed.
  • Support product compliance with a myriad of current and imminent global regulatory obligations.

Qualifications :

  • College Degree (BS) in Chemical Engineering, Chemistry, Material Science or another related field.
  • 3+ years of prior experience in a regulatory, product safety, component engineering, or data analyst role.
  • Strong attention to detail / accuracy and excellent verbal / written communication skills.
  • Demonstrated proficiency with MS Office tools - Excel, Access, PowerPoint, and Word.
  • Experience with ERP tools such as Oracle.
  • Ability to function effectively in a fast-paced environment while juggling multiple priorities.
  • Excellent organizational skills, strong customer focus and professional demeanor at all times.

Skills Required
Excel, Access, Powerpoint, Word, Organizational
This advertiser has chosen not to accept applicants from your region.

Regulatory Analyst

Bengaluru, Karnataka Confidential

Posted today

Job Viewed

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Job Description

  • Product Data Mining from regulatory data tools.
  • Engaging with IT to backfill product data into ERP systems.
  • Customer Support on regulatory document requests.
  • Vendor engagement to obtain regulatory documents and data.
  • Ongoing regulatory data analysis and tracking.
  • Analysis of materials properties and compliance status.
  • Support part / material sampling and testing process.
  • Internal global stakeholder engagement in a regulatory support function as needed.
  • Support product compliance with a myriad of current and imminent global regulatory obligations.

Qualifications :

  • College Degree (BS) in Chemical Engineering, Chemistry, Material Science or another related field.
  • 3+ years of prior experience in a regulatory, product safety, component engineering, or data analyst role.
  • Strong attention to detail / accuracy and excellent verbal / written communication skills.
  • Demonstrated proficiency with MS Office tools - Excel, Access, PowerPoint, and Word.
  • Experience with ERP tools such as Oracle.
  • Ability to function effectively in a fast-paced environment while juggling multiple priorities.
  • Excellent organizational skills, strong customer focus and professional demeanor at all times.

Skills Required
Excel, Access, Powerpoint, Word, Organizational
This advertiser has chosen not to accept applicants from your region.

Regulatory Analyst

Punjabi Bagh, Delhi Confidential

Posted today

Job Viewed

Tap Again To Close

Job Description

  • Product Data Mining from regulatory data tools.
  • Engaging with IT to backfill product data into ERP systems.
  • Customer Support on regulatory document requests.
  • Vendor engagement to obtain regulatory documents and data.
  • Ongoing regulatory data analysis and tracking.
  • Analysis of materials properties and compliance status.
  • Support part / material sampling and testing process.
  • Internal global stakeholder engagement in a regulatory support function as needed.
  • Support product compliance with a myriad of current and imminent global regulatory obligations.

Qualifications :

  • College Degree (BS) in Chemical Engineering, Chemistry, Material Science or another related field.
  • 3+ years of prior experience in a regulatory, product safety, component engineering, or data analyst role.
  • Strong attention to detail / accuracy and excellent verbal / written communication skills.
  • Demonstrated proficiency with MS Office tools - Excel, Access, PowerPoint, and Word.
  • Experience with ERP tools such as Oracle.
  • Ability to function effectively in a fast-paced environment while juggling multiple priorities.
  • Excellent organizational skills, strong customer focus and professional demeanor at all times.

Skills Required
Excel, Access, Powerpoint, Word, Organizational
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Analyst

Bangalore, Karnataka Danaher Corporation

Posted 2 days ago

Job Viewed

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Job Description

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Life Sciences, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.
We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow.
Learn about the Danaher Business System ( which makes everything possible.
The Senior Regulatory Analyst (P3) is part of an international team responsible for supporting global registrations for reagent, instrument and software products, new product development, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements.
This position reports to the Global Regulatory Manager and is part of the LS Global Regulatory affairs Team located in Bangalore and will be an on-site role.
In this role, you will have the opportunity to:
+ Perform registration dossier for all the Life Science Products in all countries (except USA)
+ Write the technical documentation for new product development
+ Maintain the adequacy with the regulation for technical documentation
+ Product lifecycle management: Support product design changes, labeling updates, sustainment, and improvement activities from regulatory perspective. Assess regulatory impact, develop detailed action plan to drive regulatory compliance and ensure on time completion of identified actions.
The essential requirements of the job include:
A Bachelor's degree in areas of life sciences or engineering field with a minimum of 12-15 years' experience in a regulated medical device/diagnostic industry (less years required with advanced degree).
+ Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean)
+ Experience in supporting filing of pre-market regulatory submissions domestically (Q-Subs, 510ks) and internationally (IVDR; China; ROW Global Registrations).
+ Knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDD/IVDR, INVIMA, ANMAT, ANVISA, COFEPRIS, ISO 13485, ISO 9001 and other applicable standards and regulations.
+ Knowledge of design control process requirements and requirements for technical documentation for in vitro diagnostics and or medical devices.
+ Experience with Software as a Medical Device (SAMD) and Software as an accessory to a device highly desirable.
Required Competencies:
+ Critical thinker able to address complex situations and issues.
+ Manages changing conditions, processes, and approaches; leads organizations through change effectively.
+ Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
+ Organized and thorough with a high level of initiative, self-motivation and energy.
+ Quick adaptability to embrace company culture and flexibility to manage multiple projects at the same time.
+ Ability to participate in meetings outside of regular business hours to support global business.
It would be a plus if you also possess previous experience in:
+ Instrument and software development in the context of medical device
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
This job is also eligible for bonus/incentive pay.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
This advertiser has chosen not to accept applicants from your region.

AML Regulatory Compliance Analyst - Hyderabad

Hyderabad, Andhra Pradesh 2coms

Posted today

Job Viewed

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Job Description

About the Client :

A Fortune 500 global leader in technology services and digitalbusiness solutions, this company delivers comprehensive Business Process Services (BPS) and IT-enabled solutions. With a worldwide presence, it serves diverse industries including banking, healthcare, retail, manufacturing, and communications. The firm's expertise spans a broad spectrum of critical processes—from finance and accounting to human resources, customer service, and supply chain management - enabling clients to enhance efficiency, drive innovation, and achieve business agility on a massive scale.

Job Title: Regulatory Compliance Analyst

Position : Subject Matter Expert(SME)
Shift :
US Shift | 5 days | Cab will be provided

CTC : Upto LPA

Location : Hyderabad, WFO
Reporting To : Operations Leader / Compliance Lead
Employment Type : Full-time

Role Summary:

The Regulatory Compliance Analyst will be responsible for supporting compliance obligations across various regulatory domains including SEC, FINRA, AML/OFAC, and insurance-related regulations. This role ensures timely and accurate reporting, supports audits and exams, and contributes to maintaining a compliant and risk-aware operational environment.

Key Responsibilities:

Regulatory Oversight & Reporting

  • Prepare and deliver compliance and regulatory reports (, market conduct exams, subpoenas, data extracts).
  • Support internal and external audits, including Early Warning Reports and TEFRA-related documentation.
  • Maintain and update compliance-related SOPs and documentation.
  • Fraud & AML/OFAC Monitoring

  • Conduct fraud investigations using tools like GIACT.
  • Monitor and report suspicious activities in alignment with AML/OFAC guidelines.
  • Collaborate with SMEs for escalations and legal signoffs.
  • Complaints & Escalations

  • Track and report customer complaints and escalated matters.
  • Licensure

  • Obtain and maintain appropriate licensure if required to support broker/dealer or securities-related services (, FINRA Series 6).
  • Documentation & Governance

  • Contribute to the development and maintenance of the Policies and Procedures Manual.
  • Participate in governance meetings and provide compliance input as needed.
  • Support the Service Provider’s reporting obligations.
  • Qualifications:

  • Bachelor’s degree in law.
  • 3+ years of experience in regulatory compliance, preferably in insurance or financial services.
  • Familiarity with SEC Rule 38a-1, Investment Company Act, FINRA Series 6/7 requirements.
  • Experience with AML/OFAC compliance and fraud detection tools.
  • Strong analytical, documentation, and communication skills.
  • Based on the job description in JD Regulatory Compliance Analyst , here’s a tailored list of competencies for the Regulatory Compliance Analyst role. These competencies are grouped into functional, technical, and behavioral categories to align with the responsibilities and qualifications outlined in the JD:
  • Functional Competencies:

  • Regulatory Reporting & Documentation
  • oAbility to prepare and deliver compliance reports (, market conduct exams, subpoenas, TEFRA documentation).

    oSkilled in maintaining and updating SOPs and compliance documentation.

  • Audit & Examination Support
  • oProficient in supporting internal and external audits, including Early Warning Reports.

    oFamiliarity with regulatory frameworks such as SEC, FINRA, and insurance-related standards.

  • Fraud & AML/OFAC Monitoring
  • oCompetence in conducting fraud investigations using tools like GIACT.

    oAbility to monitor and escalate suspicious activities in line with AML/OFAC guidelines.

  • Complaint & Escalation Management - Experience in tracking, documenting, and resolving customer complaints and escalations.
  • Licensure & Regulatory Adherence - Understanding of licensure requirements (, FINRA Series 6) and ability to maintain compliance.
  • Governance Participation - Ability to contribute to policy development and participate in governance meetings.
  • Technical Competencies

  • Regulatory Knowledge - Familiarity with SEC Rule 38a-1, Investment Company Act, and FINRA Series 6/7 requirements. In-depth knowledge of annuities and annuity regulations.
  • Compliance Tools - Experience with fraud detection and compliance monitoring tools (, GIACT).
  • Documentation & Reporting Systems - Proficiency in managing compliance documentation and reporting systems.
  • Behavioral Competencies

  • Analytical Thinking - Strong ability to analyze regulatory data and identify compliance risks.
  • Communication - Clear and effective communication skills for reporting, documentation, and stakeholder interaction.
  • Attention to Detail: High level of accuracy in preparing reports and maintaining compliance records.
  • Collaboration: Ability to work with SMEs, legal teams, and cross-functional stakeholders.
  • Adaptability: Comfortable working in a hybrid model and adjusting to evolving regulatory requirements.
  • Certifications (Preferred):

  • FINRA Series 6 or 7
  • AML Certification
  • Compliance-related training certifications

  • This advertiser has chosen not to accept applicants from your region.

    AML Regulatory Compliance Analyst - Hyderabad

    Hyderabad, Andhra Pradesh 2coms

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    About the Client :

    A Fortune 500 global leader in technology services and digital business solutions, this company delivers comprehensive Business Process Services (BPS) and IT-enabled solutions. With a worldwide presence, it serves diverse industries including banking, healthcare, retail, manufacturing, and communications. The firm's expertise spans a broad spectrum of critical processes—from finance and accounting to human resources, customer service, and supply chain management - enabling clients to enhance efficiency, drive innovation, and achieve business agility on a massive scale.


    Job Title: Regulatory Compliance Analyst

    Position : Subject Matter Expert(SME)
    Shift :
    US Shift | 5 days | Cab will be provided

    CTC : Upto 6.75 LPA

    Location : Hyderabad, WFO
    Reporting To : Operations Leader / Compliance Lead
    Employment Type : Full-time



    Role Summary:

    The Regulatory Compliance Analyst will be responsible for supporting compliance obligations across various regulatory domains including SEC, FINRA, AML/OFAC, and insurance-related regulations. This role ensures timely and accurate reporting, supports audits and exams, and contributes to maintaining a compliant and risk-aware operational environment.



    Key Responsibilities:

    Regulatory Oversight & Reporting

    • Prepare and deliver compliance and regulatory reports (e.g., market conduct exams, subpoenas, data extracts).
    • Support internal and external audits, including Early Warning Reports and TEFRA-related documentation.
    • Maintain and update compliance-related SOPs and documentation.

    Fraud & AML/OFAC Monitoring

    • Conduct fraud investigations using tools like GIACT.
    • Monitor and report suspicious activities in alignment with AML/OFAC guidelines.
    • Collaborate with SMEs for escalations and legal signoffs.

    Complaints & Escalations

    • Track and report customer complaints and escalated matters.

    Licensure

    • Obtain and maintain appropriate licensure if required to support broker/dealer or securities-related services (e.g., FINRA Series 6).

    Documentation & Governance

    • Contribute to the development and maintenance of the Policies and Procedures Manual.
    • Participate in governance meetings and provide compliance input as needed.
    • Support the Service Provider’s reporting obligations.



    Qualifications:

    • Bachelor’s degree in law.
    • 3+ years of experience in regulatory compliance, preferably in insurance or financial services.
    • Familiarity with SEC Rule 38a-1, Investment Company Act, FINRA Series 6/7 requirements.
    • Experience with AML/OFAC compliance and fraud detection tools.
    • Strong analytical, documentation, and communication skills.
    • Based on the job description in JD Regulatory Compliance Analyst 1.docx , here’s a tailored list of competencies for the Regulatory Compliance Analyst role. These competencies are grouped into functional, technical, and behavioral categories to align with the responsibilities and qualifications outlined in the JD:



    Functional Competencies:

    • Regulatory Reporting & Documentation

    o    Ability to prepare and deliver compliance reports (e.g., market conduct exams, subpoenas, TEFRA documentation).

    o    Skilled in maintaining and updating SOPs and compliance documentation.

    • Audit & Examination Support

    o    Proficient in supporting internal and external audits, including Early Warning Reports.

    o    Familiarity with regulatory frameworks such as SEC, FINRA, and insurance-related standards.

    • Fraud & AML/OFAC Monitoring

    o    Competence in conducting fraud investigations using tools like GIACT.

    o    Ability to monitor and escalate suspicious activities in line with AML/OFAC guidelines.

    • Complaint & Escalation Management - Experience in tracking, documenting, and resolving customer complaints and escalations.
    • Licensure & Regulatory Adherence - Understanding of licensure requirements (e.g., FINRA Series 6) and ability to maintain compliance.
    • Governance Participation - Ability to contribute to policy development and participate in governance meetings.



    Technical Competencies

    • Regulatory Knowledge - Familiarity with SEC Rule 38a-1, Investment Company Act, and FINRA Series 6/7 requirements. In-depth knowledge of annuities and annuity regulations.
    • Compliance Tools - Experience with fraud detection and compliance monitoring tools (e.g., GIACT).
    • Documentation & Reporting Systems - Proficiency in managing compliance documentation and reporting systems.



    Behavioral Competencies

    • Analytical Thinking - Strong ability to analyze regulatory data and identify compliance risks.
    • Communication - Clear and effective communication skills for reporting, documentation, and stakeholder interaction.
    • Attention to Detail: High level of accuracy in preparing reports and maintaining compliance records.
    • Collaboration: Ability to work with SMEs, legal teams, and cross-functional stakeholders.
    • Adaptability: Comfortable working in a hybrid model and adjusting to evolving regulatory requirements.



    Certifications (Preferred):

    • FINRA Series 6 or 7
    • AML Certification
    • Compliance-related training certifications



    This advertiser has chosen not to accept applicants from your region.

    AML Regulatory Compliance Analyst - Hyderabad

    504001 Adilabad, Andhra Pradesh 2coms

    Posted 3 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    Permanent

    About the Client :

    A Fortune 500 global leader in technology services and digital business solutions, this company delivers comprehensive Business Process Services (BPS) and IT-enabled solutions. With a worldwide presence, it serves diverse industries including banking, healthcare, retail, manufacturing, and communications. The firm's expertise spans a broad spectrum of critical processes—from finance and accounting to human resources, customer service, and supply chain management - enabling clients to enhance efficiency, drive innovation, and achieve business agility on a massive scale.

    Job Title: Regulatory Compliance Analyst

    Position : Subject Matter Expert(SME) Shift : US Shift | 5 days | Cab will be provided

    CTC : Upto 6.75 LPA

    Location : Hyderabad, WFO Reporting To : Operations Leader / Compliance Lead Employment Type : Full-time

    Role Summary:

    The Regulatory Compliance Analyst will be responsible for supporting compliance obligations across various regulatory domains including SEC, FINRA, AML/OFAC, and insurance-related regulations. This role ensures timely and accurate reporting, supports audits and exams, and contributes to maintaining a compliant and risk-aware operational environment.

    Key Responsibilities:

    Regulatory Oversight & Reporting

    Prepare and deliver compliance and regulatory reports (e.g., market conduct exams, subpoenas, data extracts).Support internal and external audits, including Early Warning Reports and TEFRA-related documentation.Maintain and update compliance-related SOPs and documentation.

    Fraud & AML/OFAC Monitoring

    Conduct fraud investigations using tools like GIACT.Monitor and report suspicious activities in alignment with AML/OFAC guidelines.Collaborate with SMEs for escalations and legal signoffs.

    Complaints & Escalations

    Track and report customer complaints and escalated matters.

    Licensure

    Obtain and maintain appropriate licensure if required to support broker/dealer or securities-related services (e.g., FINRA Series 6).

    Documentation & Governance

    Contribute to the development and maintenance of the Policies and Procedures Manual.Participate in governance meetings and provide compliance input as needed.Support the Service Provider’s reporting obligations.

    Qualifications:

    Bachelor’s degree in law. 3+ years of experience in regulatory compliance, preferably in insurance or financial services.Familiarity with SEC Rule 38a-1, Investment Company Act, FINRA Series 6/7 requirements.Experience with AML/OFAC compliance and fraud detection tools.Strong analytical, documentation, and communication skills.Based on the job description in JD Regulatory Compliance Analyst 1.docx, here’s a tailored list of competencies for the Regulatory Compliance Analyst role. These competencies are grouped into functional, technical, and behavioral categories to align with the responsibilities and qualifications outlined in the JD:

    Functional Competencies:

    Regulatory Reporting & Documentation

    o    Ability to prepare and deliver compliance reports (e.g., market conduct exams, subpoenas, TEFRA documentation).

    o    Skilled in maintaining and updating SOPs and compliance documentation.

    Audit & Examination Support

    o    Proficient in supporting internal and external audits, including Early Warning Reports.

    o    Familiarity with regulatory frameworks such as SEC, FINRA, and insurance-related standards.

    Fraud & AML/OFAC Monitoring

    o    Competence in conducting fraud investigations using tools like GIACT.

    o    Ability to monitor and escalate suspicious activities in line with AML/OFAC guidelines.

    Complaint & Escalation Management - Experience in tracking, documenting, and resolving customer complaints and escalations.Licensure & Regulatory Adherence - Understanding of licensure requirements (e.g., FINRA Series 6) and ability to maintain compliance.Governance Participation - Ability to contribute to policy development and participate in governance meetings.

    Technical Competencies

    Regulatory Knowledge - Familiarity with SEC Rule 38a-1, Investment Company Act, and FINRA Series 6/7 requirements. In-depth knowledge of annuities and annuity regulations.Compliance Tools - Experience with fraud detection and compliance monitoring tools (e.g., GIACT).Documentation & Reporting Systems - Proficiency in managing compliance documentation and reporting systems.

    Behavioral Competencies

    Analytical Thinking - Strong ability to analyze regulatory data and identify compliance risks.Communication - Clear and effective communication skills for reporting, documentation, and stakeholder interaction.Attention to Detail: High level of accuracy in preparing reports and maintaining compliance records.Collaboration: Ability to work with SMEs, legal teams, and cross-functional stakeholders.Adaptability: Comfortable working in a hybrid model and adjusting to evolving regulatory requirements.

    Certifications (Preferred):

    FINRA Series 6 or 7AML CertificationCompliance-related training certifications
    This advertiser has chosen not to accept applicants from your region.
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    Regulatory Analyst and Consultant

    Noida, Uttar Pradesh Confidential

    Posted today

    Job Viewed

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    Job Description

    Job description

    Educational Qualification:  B.E. / B. Tech and MBA in Finance/ Power Management/ Energy Management or Chartered Accountant

    Years of experience: 2 -5 Years (total)

    Relevant work experience:

    • At least 2 years of experience in leading / handling consulting projects related providing regulatory advisory services to power utilities and Regulators in India or internationally
    • Experience in preparation of tariff petitions, tariff orders, preparation of policies, regulations/codes, licensing, other regulatory matters.
    • Exposure to other areas of work including but not limited to financial analysis, PPP project advisory, etc.
    • Experience of working closely with power utilities on various activities like performance improvements (operational and/or financial), power procurement, implementation of interventions like smart metering, power market related advisory services, etc. is desirable.
    • Having good knowledge on various programs/schemes initiated by the Govt. of India, the prevailing Policy, Regulatory and power market framework.
    • Experience in managing staff and financial resources
    • Having good client relationships and industry network

    Professional Skills

    • Excellent verbal, interpersonal and written communication skills
    • Proficiency in MS Office Applications
    • Willingness to work on a flexible work schedule, and travel as the job requires
    • Ability to handle multiple projects simultaneously
    • Strong attention to detail and organization
    • Technical problem solving, project management, dependability, initiative and professionalism are of the utmost importance

    Responsibilities:

    • Carrying out business development initiatives
    • Business development by leveraging existing relationships and through acquisition of new clients
    • Leading engagement execution across sectors and guiding team to ensure engagement deliverables are completed to client satisfaction
    • Ensure timely billing and collection
    • Support in development of suitable templates and tools to support practice
    • Support in recruitment and team building
    • Ensuring compliance of engagement risk management

    Skills Required
    Asian CERC, Tariff, Regulatory, WISE
    This advertiser has chosen not to accept applicants from your region.

    Regulatory Affairs Analyst

    Bangalore, Karnataka Danaher Corporation

    Posted 2 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    Bring more to life.
    Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
    At Beckman Coulter Life Sciences, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
    You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
    At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.
    We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
    It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow.
    Learn about the Danaher Business System ( which makes everything possible.
    The Regulatory Affairs Analyst is part of an international team responsible for supporting global registrations for reagent, instrument and software products, new product development, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements.
    This position reports to the Global Regulatory Manager and is part of the LS Global Regulatory affairs Team located in Bangalore and will be an on-site role.
    In this role, you will have the opportunity to:
    + Perform registration dossier for all the Life Science Products in all countries (except USA)
    + Participate to gathering the technical documentation for new product development
    + Maintain the adequacy with the regulation for technical documentation
    + Product lifecycle management: Support product design changes, labeling updates, sustainment, and improvement activities from regulatory perspective. Assess regulatory impact, develop detailed action plan to drive regulatory compliance and ensure on time completion of identified actions.
    The essential requirements of the job include:
    A Bachelor's degree in areas of life sciences or engineering field with a minimum of 8 - 10 years experience in a regulated medical device/diagnostic industry (less years required with advanced degree).
    + Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean)
    + Experience in supporting filing of pre-market regulatory submissions domestically (Q-Subs, 510ks) and internationally (IVDR; China; ROW Global Registrations).
    + Knowledge of domestic and international quality systems and other standards such as, IVDD/IVDR, ISO 13485, ISO 9001 and other applicable standards and regulations.
    + Experience with Software as a Medical Device (SAMD) and Software as an accessory to a device highly desirable.
    Required Competencies:
    + Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
    + Quick adaptability to embrace company culture and flexibility to manage multiple projects at the same time.
    + Ability to participate in meetings outside of regular business hours to support global business.
    It would be a plus if you also possess previous experience in:
    + Instrument and software development in the context of medical device
    Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
    This job is also eligible for bonus/incentive pay.
    Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
    Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
    For more information, visit .
    This advertiser has chosen not to accept applicants from your region.
     

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