521 Pharmaceutical Regulatory jobs in India
Pharmaceutical Regulatory Affairs Specialist
110001 Delhi, Delhi
₹900000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a meticulous and experienced Pharmaceutical Regulatory Affairs Specialist to join their team in Delhi . This role is crucial for ensuring compliance with all national and international regulatory requirements for drug development, registration, and marketing. The ideal candidate will possess a deep understanding of pharmaceutical regulations, excellent documentation skills, and a proactive approach to navigating the complex regulatory landscape.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., CTD, eCTD) for new drug applications (NDAs), variations, and post-approval changes.
- Liaise with regulatory health authorities (e.g., CDSCO, US FDA, EMA) for timely approvals and responses to queries.
- Monitor and interpret regulatory guidelines, changes, and trends affecting the pharmaceutical industry.
- Ensure all labeling, promotional materials, and advertising comply with regulatory requirements.
- Manage product registration and lifecycle management activities.
- Collaborate with R&D, clinical, quality assurance, and marketing departments to gather necessary information for regulatory submissions.
- Provide regulatory guidance and strategic advice to project teams throughout the product development lifecycle.
- Maintain regulatory databases and filing systems.
- Review and approve technical documents for regulatory compliance.
- Participate in regulatory inspections and audits.
- Stay updated on therapeutic areas and competitive regulatory intelligence.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of Indian and relevant international pharmaceutical regulations.
- Proven experience in preparing and submitting regulatory dossiers.
- Excellent written and verbal communication skills, with strong attention to detail.
- Proficiency in regulatory affairs software and databases.
- Strong analytical and problem-solving abilities.
- Ability to work independently and as part of a collaborative team.
- Strong organizational and project management skills.
- Familiarity with GMP, GLP, and GCP guidelines.
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Executive (Pharmaceutical)
Ahmedabad, Gujarat
Brilliant Lifesciences Pvt.ltd.
Posted 1 day ago
Job Viewed
Job Description
Regulatory Affairs Executive
( For Pharmaceutical Tablet manufacturing Company)
1) Dossier Preparation ( For ROW markets - African - Asian and CIS countries)
2) Dossier Review ( For ROW markets - African - Asian and CIS countries)
3) Knowledge about Countries wise FDA registration - Facility registration - product Registration
Pay: ₹30,000.00 - ₹50,000.00 per month
**Benefits**:
- Food provided
- Health insurance
Schedule:
- Fixed shift
Ability to commute/relocate:
- Detroj, Gujarat: Reliably commute or planning to relocate before starting work (preferred)
**Education**:
- Master's (preferred)
**Experience**:
- total work: 8 years (preferred)
- FDA regulations: 8 years (preferred)
- CGMP: 8 years (preferred)
- Documentation review: 8 years (preferred)
- Document management: 8 years (preferred)
Work Location: In person
( For Pharmaceutical Tablet manufacturing Company)
1) Dossier Preparation ( For ROW markets - African - Asian and CIS countries)
2) Dossier Review ( For ROW markets - African - Asian and CIS countries)
3) Knowledge about Countries wise FDA registration - Facility registration - product Registration
Pay: ₹30,000.00 - ₹50,000.00 per month
**Benefits**:
- Food provided
- Health insurance
Schedule:
- Fixed shift
Ability to commute/relocate:
- Detroj, Gujarat: Reliably commute or planning to relocate before starting work (preferred)
**Education**:
- Master's (preferred)
**Experience**:
- total work: 8 years (preferred)
- FDA regulations: 8 years (preferred)
- CGMP: 8 years (preferred)
- Documentation review: 8 years (preferred)
- Document management: 8 years (preferred)
Work Location: In person
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Officer (pharmaceutical Company) Dombivli
Thane, Maharashtra
Double HR Consultancy
Posted today
Job Viewed
Job Description
regulatory affairseducation: /.salary: 5 lpa to 6 lpajob location: dombivli east midc
Experience
5 - 6 Years
No. of Openings
3
Education
B.Sc, M.Sc
Role
Regulatory Officer
Industry Type
Pharma / BioTech / Clinical Research
Gender
Male
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Affairs Specialist
Gurugram, Uttar Pradesh
Stryker
Posted 2 days ago
Job Viewed
Job Description
**What you will do**
**Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.**
**Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.**
**Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.**
**Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.**
**Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.**
**Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.**
**Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.**
**Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.**
**Determining and communicating submission and approval requirements.**
**What you need:**
**Required-**
**Bachelor's or Master's degree in Regulatory Affairs, Engineering or equivalent discipline is required.**
**3 - 5 years experience**
**Preferred-**
**Experience with post-market and change management is a distinct advantage**
**RAC Certification is preferred**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
**Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.**
**Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.**
**Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.**
**Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.**
**Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.**
**Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.**
**Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.**
**Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.**
**Determining and communicating submission and approval requirements.**
**What you need:**
**Required-**
**Bachelor's or Master's degree in Regulatory Affairs, Engineering or equivalent discipline is required.**
**3 - 5 years experience**
**Preferred-**
**Experience with post-market and change management is a distinct advantage**
**RAC Certification is preferred**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Specialist
Ahmedabad, Gujarat
Frisch Medical Devices PVT LTD
Posted 4 days ago
Job Viewed
Job Description
Job Title: Regulatory Affairs Junior Manager
Location: At Ahmedabad Office , Near Thaltej Crossroads
Department: RA
Reports To: RA Head and Regulatory Department at HO /Director
Employment Type: Full Time
Office hours : 9,30 AM to 6 PM
Week of: Sunday and Saturday Half Day
Preferred Gender : M/F
Experience : Minimum 2 years
Job Summary:
We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.
Key Responsibilities:
- Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
- Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
- Support product development teams with regulatory input during the design and development phases.
- Conduct regulatory impact assessments for design or process changes.
- Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
- Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
- Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
- Assist in internal audits and inspections, including document preparation and response coordination.
- Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
- Participate in risk management, clinical evaluation, and post-market surveillance activities.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
- Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
- Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
- Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
- Strong analytical, organizational, and communication skills.
- Attention to detail and ability to work independently as well as in a team environment.
Preferred Qualifications:
- Certification in Regulatory Affairs (e.g., RAC) is a plus.
- Experience interacting with regulatory bodies or notified bodies.
- Familiarity with eCTD or electronic submission platforms.
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Specialist
Mumbai, Maharashtra
Anmol Chemicals Pvt. Ltd.
Posted 4 days ago
Job Viewed
Job Description
Job Summary:
- We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.
Essential Duties and Responsibilities :
- Regulatory Compliance : Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations.
- Submission Management : Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.
- Software: Good knowledge about regulatory software’s like, Pharmareddy, eCTD Global, Educe Solution.
- Competency: Thorough knowledge in filling DMF/Master files/Submissions to countries like Europe/UK, Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, Mexico.
- Login/Account Creation: Having knowledge to make Company Login/Account Creation on all Countries Regulatory Portals.
- Regulatory Strategy : Develop and implement regulatory strategies to support product development and commercialization.
- Regulatory Intelligence : Stay up-to-date with changing regulatory requirements and provide guidance to internal stakeholders.
- Audits and Inspections : Coordinate and manage regulatory audits and inspections.
- Labeling and Advertising : Review and approve product labeling and advertising materials for regulatory compliance.
- Regulatory Agency Interactions : Communicate with regulatory agencies, such as the FDA, to address questions and concerns.
- Regulatory Documentation : Maintain and manage regulatory documents, such as regulatory submissions, approvals, and correspondence.
- Document Preparation: having knowledge about or can solo prepare all the Regulatory applications submission data for all countries.
- Training and Guidance : Provide regulatory training and guidance to internal stakeholders.
- Compliance Monitoring : Monitor company activities for compliance with regulatory requirements.
Skills :
- Must have good knowledge of Regulatory Submissions
- Must have good knowledge of Regulatory Research
- Must be familiarity with chemical industry specific regulations and guidelines.
This advertiser has chosen not to accept applicants from your region.
5
Regulatory Affairs Specialist
Mumbai, Maharashtra
Anmol Chemicals Pvt. Ltd.
Posted today
Job Viewed
Job Description
Job Summary:
- We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.
Essential Duties and Responsibilities:
- Regulatory Compliance: Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations.
- Submission Management: Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.
- Software: Good knowledge about regulatory software’s like, Pharmareddy, eCTD Global, Educe Solution.
- Competency: Thorough knowledge in filling DMF/Master files/Submissions to countries like Europe/UK, Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, Mexico.
- Login/Account Creation: Having knowledge to make Company Login/Account Creation on all Countries Regulatory Portals.
- Regulatory Strategy: Develop and implement regulatory strategies to support product development and commercialization.
- Regulatory Intelligence: Stay up-to-date with changing regulatory requirements and provide guidance to internal stakeholders.
- Audits and Inspections: Coordinate and manage regulatory audits and inspections.
- Labeling and Advertising: Review and approve product labeling and advertising materials for regulatory compliance.
- Regulatory Agency Interactions: Communicate with regulatory agencies, such as the FDA, to address questions and concerns.
- Regulatory Documentation: Maintain and manage regulatory documents, such as regulatory submissions, approvals, and correspondence.
- Document Preparation: having knowledge about or can solo prepare all the Regulatory applications submission data for all countries.
- Training and Guidance: Provide regulatory training and guidance to internal stakeholders.
- Compliance Monitoring: Monitor company activities for compliance with regulatory requirements.
Skills :
- Must have good knowledge of Regulatory Submissions
- Must have good knowledge of Regulatory Research
- Must be familiarity with chemical industry specific regulations and guidelines.
This advertiser has chosen not to accept applicants from your region.
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6
Regulatory Affairs Specialist
Ahmedabad, Gujarat
Frisch Medical Devices PVT LTD
Posted today
Job Viewed
Job Description
Job Title: Regulatory Affairs Junior Manager
Location: At Ahmedabad Office , Near Thaltej Crossroads
Department: RA
Reports To: RA Head and Regulatory Department at HO /Director
Employment Type: Full Time
Office hours : 9,30 AM to 6 PM
Week of: Sunday and Saturday Half Day
Preferred Gender : M/F
Experience: Minimum 2 years
Job Summary:
We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices. The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.
Key Responsibilities:
- Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
- Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
- Support product development teams with regulatory input during the design and development phases.
- Conduct regulatory impact assessments for design or process changes.
- Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
- Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
- Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
- Assist in internal audits and inspections, including document preparation and response coordination.
- Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
- Participate in risk management, clinical evaluation, and post-market surveillance activities.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
- Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices.
- Knowledge of medical device regulations such as EU MDR, US FDA 21 CFR Part 820, ISO 13485, and CDSCO requirements.
- Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
- Strong analytical, organizational, and communication skills.
- Attention to detail and ability to work independently as well as in a team environment.
Preferred Qualifications:
- Certification in Regulatory Affairs (e.g., RAC) is a plus.
- Experience interacting with regulatory bodies or notified bodies.
- Familiarity with eCTD or electronic submission platforms.
This advertiser has chosen not to accept applicants from your region.
7
Regulatory Affairs Specialist
600007 Lucknow, Uttar Pradesh
₹55000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a prominent pharmaceutical company, is seeking a dedicated Regulatory Affairs Specialist to join their team in **Lucknow, Uttar Pradesh, IN**. This role is vital for ensuring that all pharmaceutical products meet stringent regulatory requirements throughout their lifecycle, from development to post-market surveillance. The ideal candidate will possess a solid understanding of pharmaceutical regulations, submission processes, and quality management systems, with excellent attention to detail and analytical skills.
Key Responsibilities:
Qualifications:
This hybrid role allows for a combination of on-site work and remote flexibility, supporting regulatory strategy and compliance.
Key Responsibilities:
- Prepare and submit regulatory filings, such as New Drug Applications (NDAs), Investigational New Drug (IND) applications, and variations, to health authorities.
- Review and approve product labeling, promotional materials, and advertising content for regulatory compliance.
- Maintain up-to-date knowledge of global and regional pharmaceutical regulations and guidelines.
- Liaise with regulatory agencies, respond to queries, and manage regulatory correspondence.
- Ensure that company procedures and practices comply with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GPvP).
- Assess the regulatory impact of product changes and implement necessary submissions.
- Collaborate with R&D, Quality Assurance, Manufacturing, and Marketing departments to ensure regulatory requirements are met.
- Manage the lifecycle of regulatory submissions and maintain regulatory databases.
- Conduct regulatory intelligence activities to identify emerging trends and opportunities.
- Provide regulatory guidance and support to internal teams.
- Participate in regulatory audits and inspections.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 3-5 years of experience in pharmaceutical regulatory affairs.
- Strong knowledge of regulatory submission processes and guidelines (e.g., FDA, EMA, CDSCO).
- Experience with dossier preparation and submission management.
- Excellent written and verbal communication skills, with strong attention to detail.
- Proficiency in regulatory information management systems.
- Ability to analyze complex scientific and technical data.
- Strong problem-solving and decision-making abilities.
- Ability to work independently and collaboratively in a team environment.
- Familiarity with pharmaceutical product development and manufacturing processes.
This hybrid role allows for a combination of on-site work and remote flexibility, supporting regulatory strategy and compliance.
This advertiser has chosen not to accept applicants from your region.
8
Regulatory Affairs Specialist
Ahmedabad, Gujarat
Frisch Medical Devices PVT LTD
Posted 4 days ago
Job Viewed
Job Description
Job Title: Regulatory Affairs Junior Manager
Location: At Ahmedabad Office , Near Thaltej Crossroads
Department: RA
Reports To: RA Head and Regulatory Department at HO /Director
Employment Type: Full Time
Office hours : 9,30 AM to 6 PM
Week of: Sunday and Saturday Half Day
Preferred Gender : M/F
Experience : Minimum 2 years
Job Summary:
We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.
Key Responsibilities:
Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
Support product development teams with regulatory input during the design and development phases.
Conduct regulatory impact assessments for design or process changes.
Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
Assist in internal audits and inspections, including document preparation and response coordination.
Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
Participate in risk management, clinical evaluation, and post-market surveillance activities.
Qualifications:
Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
Strong analytical, organizational, and communication skills.
Attention to detail and ability to work independently as well as in a team environment.
Preferred Qualifications:
Certification in Regulatory Affairs (e.g., RAC) is a plus.
Experience interacting with regulatory bodies or notified bodies.
Familiarity with eCTD or electronic submission platforms.
Location: At Ahmedabad Office , Near Thaltej Crossroads
Department: RA
Reports To: RA Head and Regulatory Department at HO /Director
Employment Type: Full Time
Office hours : 9,30 AM to 6 PM
Week of: Sunday and Saturday Half Day
Preferred Gender : M/F
Experience : Minimum 2 years
Job Summary:
We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.
Key Responsibilities:
Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
Support product development teams with regulatory input during the design and development phases.
Conduct regulatory impact assessments for design or process changes.
Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
Assist in internal audits and inspections, including document preparation and response coordination.
Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
Participate in risk management, clinical evaluation, and post-market surveillance activities.
Qualifications:
Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
Strong analytical, organizational, and communication skills.
Attention to detail and ability to work independently as well as in a team environment.
Preferred Qualifications:
Certification in Regulatory Affairs (e.g., RAC) is a plus.
Experience interacting with regulatory bodies or notified bodies.
Familiarity with eCTD or electronic submission platforms.
This advertiser has chosen not to accept applicants from your region.
9