7,359 Regulatory Standards jobs in India
Manager - Regulatory & Technical Standards Compliance
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Job Description
Job ID: 36710
Location: Bangalore, IN
Area of interest: Technology
Job type: Regular Employee
Work style: Office Working
Opening date: 11 Aug 2025
Job Summary
The role will work closely with Country CISOs / ISRO / CISRO / ICS / TTO representatives within the bank to ensure the Banks ICS regulatory obligations are met on time.
The Group Chief Information Security Officer (CISO) organisation is instrumental in protecting and ensuring the resilience of Standard Chartered Bank's data and IT systems by managing information and cyber security (ICS) risk across the enterprise. As a critical function reporting into the Group Chief Technology, Operations and Transformation Officer, the Group CISO serves as the first line of defence for assuring ICS controls are implemented effectively and in accordance with the ICS Risk Framework, Policy and Standard, and for instilling a culture of cyber security within the Bank.
This includes supporting the ICS Legal Regulatory Mandatory compliance assessments for all markets.
Key Responsibilities
Business
- The role will work closely with Country CISOs / ISRO / CISRO / ICS / TTO representatives within the bank to ensure the Banks ICS regulatory obligations are met on time.
Processes
The role will:
- The role is responsible to complete regulatory compliance assessments and support all SCB regions in meeting critical and complex ICS regulatory obligations.
- The role oversees all ICS regulatory compliance assessment activities (design and operating effectiveness), supports issue remediations and ensures these are performed to quality and submitted to regulators on time.
- The role requires technical ICS domain knowledge, SME skills in regulatory compliance assessments / audit / risk & control, and strong senior stakeholder management abilities (RCISO, CISO, ISRO, ICS/Technology/CIO Domains).
- Regularly identify and implement opportunities for efficiencies across processes, systems, and infrastructure.
People & Talent Management
- Working in close collaboration with CISO, risk and control partners across all functions to effectively embed a strong culture of risk awareness and good conduct,
- Track and sustain a continuous improvement and innovation culture,
- Support a culture of diversity and inclusion to bring the best out of our people,
Risk Management
- Work closely with AIC LRM cluster leads to drive an effective risk management culture and compliance mindset,
- Mature the Bank's ability to proactively identify and manage cyber threats through quality compliance assessments at a Design and Operating level
Governance
- Track and follow up for timely and accurate completion of ICS regulatory compliance assessments and ensure all governance metrics are met
- Support appropriate oversight and follow-up for resolution of high impact risk and issues
Regulatory & Business Conduct
- Display exemplary conduct and live by the Group's Values and Code of Conduct. Including tracking and remediation of conduct issues
- Effectively and collaboratively support to identify, escalate, mitigate, and resolve risk, conduct and compliance matters.
Key Stakeholders
- Head, App & Infra Compliance
- AVP / VP, LRM App & Infra Compliance
- Regional and Country - Chief Information Security Officers (CISOs) and delegate
- Information Security Risk Officers and delegate
- ICS Service domains
- COOs/CIOs of different businesses/functions
- Group Internal Audit
Other Responsibilities
- Embed Here for good and Group's brand and values in ICS R&G; Perform other responsibilities assigned under Group, Country, Business or Functional policies and procedures; Multiple functions (double hats);
Skills and Experience
- Business Process Design
- Process Management
- Risk Management
- Regulatory Environment – Financial Services
- Program Management
Qualifications
- Minimum 10 years of experience in Cyber Security, technology and ICS risk management, A proven track record of leading successful teams is priority.
- Excellent interpersonal skills to foster positive relationships with internal and external stakeholders.
- Thorough understanding of ICS business processes, risks, threats, internal controls, and experience with regulators and multi-stakeholder organisations.
- Ability to collect and analyse data and make recommendations in written and oral form.
- Strong ability to liaise with all parts of the Bank, including senior security, risk and business stakeholders.
- Highly effective oral and written communication skills, with an ability to influence and to gain the respect of senior stakeholders and peers. Fluency in English.
- Bachelor's Degree in Information Technology, Cybersecurity, Business Management, or other related discipline. Professional certifications have an advantage (e.g., CISA, CISSP, CISM etc).
About Standard Chartered
We're an international bank, nimble enough to act, big enough for impact. For more than 170 years, we've worked to make a positive difference for our clients, communities, and each other. We question the status quo, love a challenge and enjoy finding new opportunities to grow and do better than before. If you're looking for a career with purpose and you want to work for a bank making a difference, we want to hear from you. You can count on us to celebrate your unique talents and we can't wait to see the talents you can bring us.
Our purpose, to drive commerce and prosperity through our unique diversity, together with our brand promise, to be here for good are achieved by how we each live our valued behaviours. When you work with us, you'll see how we value difference and advocate inclusion.
Together we:
- Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do
- Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well
- Are better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term
What we offer
In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing.
- Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations.
- Time-off including annual leave, parental/maternity (20 weeks), sabbatical (12 months maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum.
- Flexible working options based around home and office locations, with flexible working patterns.
- Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits
- A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning.
- Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies - everyone feels respected and can realise their full potential.
Quality Assurance Regulatory Affairs Manager
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Key Responsibilities:
Develop and implement quality management systems (QMS) compliant with ISO 13485 and FDA regulations
Conduct audits and inspections to ensure compliance with quality standards.
Manage corrective and preventive actions (CAPA) and implement quality improvements.
Get all the compliance, licensing, audits done under his responsibility.
Regulatory Affairs:
Ensure compliance with regulatory requirements for medical devices, including FDA, CE, and other relevant regulations.
Manage regulatory submissions
Monitor and analyze regulatory changes and updates, and implement necessary changes.
Collaborate with teams to ensure labeling and advertising compliance.
Requirements:
Bachelor's degree in a relevant field (e.g., engineering, science).
Experience in quality assurance and regulatory affairs in the medical device industry.
Knowledge of QMS standards (ISO and regulatory requirements (FDA, CE).
Strong analytical and problem-solving skills.
Excellent communication and leadership skills.
Interested candidates can apply with us with their updated cv & cover letter or connect with us over whatsapp to take your candidature further.
Quality Assurance Regulatory Affairs Manager
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**Company Description
Elesonic Group, originally founded in 1965, has grown substantially since establishing its in-house X-ray machine manufacturing plant in 2006. Elesonic Healthcare Private Limited, based on the outskirts of Kolkata with a National Sales office in Central Kolkata, specializes in manufacturing medical equipment like X-ray and C-arm machines. By 2019, Elesonic expanded its operations to African Union through offices at Nigeria and Uganda. Same Year in 2019 Elesonic established a presence in Canada for Trans atlantic operation including Carribean Islands. Our pledge is to deliver quality and exceptional service in the industry. Join us in making the world a healthier place
Role Description
This is a full-time, on-site role for a Quality Cum Regulatory Assurance Executive located in Kolkata. The role involves overseeing and implementing quality control and assurance processes, conducting quality audits, and managing quality systems. The executive will ensure compliance with regulatory standards and work closely with various departments ( I.E - AERB / BIS / CDSCO / EUROPEAN AGENCY FOR ISO AND CE ) to maintain high-quality manufacturing standards for medical equipment.
Qualifications
- Implementing and acheiving Quality Control, Quality Assurance, and Quality Management skills Experience in Quality Control and Quality Assurance processes
- Proficiency in Quality Management systems and practices
- Knowledge of Medical Device Regulations (i.e - AERB / BIS / CDSCO / ISO 13485 European / CE European )
- Strong analytical and problem-solving skills
- Excellent attention to detail and organizational abilities
- Ability to work effectively in a team and independently
- Bachelor's degree in a related field (e.g., Life Sciences, Engineering, or Quality Management
- Must Have Physics one of the Subject in Bachelor's Degree
- Radiological Safety Officer ( RSO ) Exam from AERB passed is preffered and if not passed then have the ability to pass
- Prior experience in the medical equipment industry is a plus**
Regulatory Affairs and Quality Assurance Engineer
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Join us in pioneering breakthroughs in healthcare. For everyone. Everyw Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
The RA/QA Engineer typically serves as the quality representative on the project team and works closely with the project team leader.
Responsible for minimizing risk to the organization associated with product design and realization efforts and assists in ensuring robust medical device product designs under governing domestic and international requirements.
Provides support and typically works as a member of one or more new product development and/or sustaining engineering projects.
Major on-going responsibilities for, but not limited to:
- Is a member of Pune engineering team and has the responsibility and authority for ensuring Quality System requirements are established and maintained in accordance with applicable quality procedures of Varian Product Life Cycle (PLC)
- Participate in reviews of designs and design documentation to ensure that all domestic, international engineering practices, Quality System documentation, laws and regulations are being met consistently.
- Support Quality group during internal/external audits with respect to internal Quality System documentation and all appropriate regulations.
- Review ECN's to ensure compliance to Quality System, QSR and International standards and requirements for Product Life Cycle (PLC) and sustaining activities.
- Ensure that product development projects and changes to existing products are conducted in compliance with all appropriate regulations and standards.
- Work with teams to ensure successful transfer of new products to manufacturing. Review production processes for quality of Process Validation.
- Provide input to the creation of Design Verification and Validation protocols and test reports.
- Provide guidance and direction for sample size and statistical analysis for testing.
- Provide guidance and/or training to project teams on procedures, Design Verification and Validation, statistical methods and Design Controls.
- Review Design History Files for conformance to applicable requirements.
- Supports Regulatory Affairs regarding regulatory submissions e.g. 510(k) submissions containing medical device software.
- Understand and be able to review software development lifecycle records for compliance with good documentation practices.
- Maintain a complete awareness of the cost of quality and promote activities to monitor and reduce quality costs.
- Provide external supplier support as required.
- May be responsible for specific SME (Subject Matter Expert) support, general improvement projects and support of CAPAs.
Quality Engineering Ownership
- Phase End Design Reviews – drives compliance of the review, reviews document and provides DHF reviews.
- Provides Software Summary Assessment
- Provides Post Market surveillance and customer complaint data for design inputs including; Complaints, CAPAs, Journals, Customer Surveys and Audit Findings.
Obtains and distributes on-going metrics for review by relevant teams:
- ECN – post launch (not continuous improvements)
- Number of Recalls – by type
- Number of Discrepancy Reports (by priority and phase discovered)
- Complaint analysis as pertaining to Design Control
- Tracking of scheduled delays (length / cause)
Provides Quality Reviews for:
- Phase End Design Reviews – drives compliance of the review, reviews document and provides DHF reviews.
- Provides Software Summary Assessment
- Provides Post Market surveillance and customer complaint data for design inputs including; Complaints, CAPAs, Journals, Customer Surveys and Audit Findings.
- Obtains and distributes on-going metrics for review by relevant teams:
- ECN – post launch (not continuous improvements)
- Number of Recalls – by type
- Number of Discrepancy Reports (by priority and phase discovered)
- Complaint analysis as pertaining to Design Control
Tracking of scheduled delays (length / cause)
Characteristics
- Ability to manage multiple projects simultaneously without supervision.
- Provide authoritative guidance to all appropriate regulations, safety standards and internal Quality System processes.
- Ability to monitor and analyze process and product data statistically and identify improvement opportunity.
- Ability to write / review software test scripts manual / automated
- Able to work with project teams effectively. Gains buy-in on new ideas and able to give feedback without offending.
- Must be able to manage and meet personal commitments.
- Not only provides input but also provides potential solutions.
- Excellent communication, problem solving and interpersonal skills (teams).
- Effective skills in analytical thinking and problem solving.
Team player.
Qualifications
- Bachelor's degree in computer science, Engineering or related technical field required. Master's degree or equivalent preferred.
- 4-6 years' experience of working on either of healthcare software lifecycle phase like design and development, testing, or customer facing activities.
- Experience of healthcare software (medical device software or EMR, EHR) related customer requirement gathering, solution development, verification and validation testing, customer acceptance, complaint handing is preferred.
- Experience of working in regulated industry of medical device is added advantage.
- Working knowledge of software development and/or electrical/mechanical engineering.
- Experience of working with healthcare provider that follows ISO 13485, ISO 14971, IEC 62304, FDA QSR 21 CFR 820, EU Directive 93/42 EEC, EU MDR 2017/745, MDSAP or similar medical device regulations.
- Professional certification (i.e. SQA-Software Quality Assurance, Certified Internal/Lead Auditor for ISO is added advantage.
- Requires excellent written and verbal communication skills.
Ability to relocate to work location to work with geographically diverse and international teams.
Who we are : We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work : When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everyw Sustainably.
To find out more about Healthineers' specific businesses, please visit our company page here .
As an equal opportunity employer, we welcome applications from individuals with disabilities.
Data Privacy : We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile where you can upload your CV. Setting up a profile also lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.
Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.
To all recruitment agencies : Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. As an equal opportunity employer, we welcome applications from individuals with disabilities.
Quality Assurance
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Role & responsibilities
RESPONSIBILITIES: -
To follow the cGMP Rules and regulation.
Documentation Control: maintenance, updation and issuance of documents in compliance with regulatory requirements and implementation of Good Documentation Practices.
Review and approval of all Master documents like SOP, Batch Manufacturing record, Batch packing record, Calibration schedule, Preventive maintenance Schedule and other quality related documents
Responsible for preparation and review of protocol and report for Process validation, Cleaning validation as per the schedule and validation master plan.
Handling of documents like SOPs, formats / Annexures, Log Books, BMR / BPR & all other GMP Documents like Change control, deviation, incident, CAPA, breakdown slips etc
Responsible for preparation, review and approval of DQ, IQ, OQ and PQ documents for new equipment or existing equipment
Responsible for handling of change controls & implementation of changes.
Responsible for review of all batch related documentation, to support Quality Head to release the product, to support and maintain Environmental Health and Safety requirements as applicable.
To perform & review of risk assessments.
Review & signing of Finished Product data & Certificate of Analysis & product release certificate.
Responsible for review & signing of product stability data
Responsible for preparation/execution of Self Inspection.
Responsible for Annual product quality review reports.
Responsible for handling & maintenance of control / retain samples.
Responsible for review & updation of Batch Manufacturing / Packing records & its issuance.
Responsible for review, updation & maintenance of Master Formula Records.
To plan and execute employees training about departmental SOPs.
Responsible for review the SOPs of Quality Assurance department.
To review of product stability data, Control and retain sample evaluation record
To review & approve all the specifications & standard testing procedure
Responsible for Implementation & to check effectiveness of all regulatory requirements.
To support regulatory department related to documentation & dossier submission activities and to resolve the received technical queries.
Responsible for review & approval of artworks
To review & approve shade cards.
Responsible for review & approval of Bill of Materials.
Execution and review of Aseptic process simulation study
To support IPQA head / team as and when required
To support Validation / Qualification head / team as and when required
To check the effectiveness of GEP (Good engineering practices) at service floor, HVAC system, water system, Nitrogen system and Compressed air system.
Review of APQR
Responsible to inform any Non- Conformity observed in area to Head of the Department
Approve or rejecting starting materials, packing materials, intermediate and bulk roducts in relation to their specifications & batch release.
To prepare/approve risk assessment documents.
To participate in external audit.
Handling of recall.
To approve and monitor analyses carried out under contract.
To ensure maintenance of department, premises and equipment.
To ensure appropriate validations including those of analytical procedures and calibrations of control equipment are carried out.
To ensure training of personnel is carried out.
To approve/authorize personnel of all department.
To approve gowning qualification of personnel.
To ensure/ maintain archival system of documents.
Any assignment other than above responsibility given by reporting authority.
Maintenance of Job responsibilities, Organograms & Specimen signature logs
Preferred candidate profile
Majorly who Have experience in Injectable and Team Handling
Quality Assurance
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Experience Into IPQA / QMS/ Qualification
Interview will be held in Pune.
Required Candidate profile
2-8 Years Of Experience Into
IPQA / QMS/ Qualification
Quality Assurance
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Job Description
Quality Assurance (QA) Engineer
Experience - 0-6 Month
Location - Indore (WFO)
Immediately Joiner
We are seeking a Quality Assurance Engineer to ensure the quality and reliability of our software applications. The ideal candidate will be detail-oriented, skilled in testing methodologies, and passionate about delivering high-quality products.
Key Responsibilities
Review requirements, specifications, and technical documents to provide timely feedback.
Design, develop, and execute test cases (manual and automated).
Identify, document, and track bugs using issue-tracking tools (e.g., Jira, Bugzilla).
Perform functional, regression, integration, performance, and security testing.
Collaborate with developers, product managers, and other stakeholders to ensure software quality.
Maintain test documentation and prepare test reports.
Contribute to continuous improvement of QA processes and best practices.
Required Skills & Qualifications
Bachelor's degree in Computer Science, IT, or related field.
Proven experience in software testing (manual and/or automation).
Strong knowledge of QA methodologies, tools, and processes.
Hands-on experience with test management and bug-tracking tools (e.g., Jira, TestRail).
Good understanding of SDLC and Agile methodologies.
Strong analytical and problem-solving skills.
Excellent communication and teamwork abilities.
Knowledge of performance testing tools (JMeter, LoadRunner).
Job Types: Full-time, Fresher
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Quality Assurance
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Job Title: Quality Assurance Executive Essential Oils
Company: Aromaaz International Pvt. Ltd.
Location: (Ghaziabad)
Job Type: Full-time
Key Responsibilities:
1-Ensure quality of essential oils, absolutes, carrier oils, and related natural products in compliance with international standards.
2-Conduct physical, chemical, and sensory evaluation of raw materials and finished goods.
3-Maintain GC-MS (Gas Chromatography-Mass Spectrometry) and other analytical reports for quality verification.
4-Develop, implement, and monitor SOPs for quality control and assurance across production and packaging units.
5-Coordinate with suppliers and vendors to ensure raw material quality.
6-Ensure adherence to export regulations, safety standards, and certifications (ISO, GMP, HACCP, FSSAI, etc.).
7-Handle documentation, quality reports, COA (Certificate of Analysis), and batch records.
Support R&D and production teams in resolving quality-related issues.
Requirements:
1-Bachelors/Master's degree in Chemistry, Food Technology, Essential Oils, or related field.
2- 1–3 years of experience in Quality Assurance/Quality Control, preferably in essential oils, fragrances, or FMCG export industry.
3-Strong knowledge of analytical instruments like GC-MS, HPLC, and related testing methods.
4-Good understanding of international quality standards and export documentation.
5-Excellent attention to detail, problem-solving, and reporting skills.