Head - Quality & Regulatory Compliance

4 weeks ago


Mumbai, Maharashtra, India Getinge Full time

Job Overview:

We are seeking an experienced and visionary Head of Quality and Regulatory Compliance (QRC) to lead and oversee all aspects of Quality Assurance and Regulatory Affairs in India.

This senior leadership role is responsible for ensuring compliance with Medical Devices Rules 2017 and global quality standards, while building and executing a long-term strategy for QRC excellence in India.

As a key member of the SAPAC QRC Leadership Team and the India SSU Leadership Team, the incumbent will provide strategic direction, regulatory expertise, and operational leadership to ensure effective product registrations, quality system compliance, and post-market vigilance.

The role has a solid reporting line to the Senior QRC Director, APAC and a dotted line to the Managing Director, India SSU.

Key Responsibilities:

Strategic Leadership & Compliance (30%):

- Define, implement, and oversee the local Quality Management System (QMS) in alignment with Global Sales QMS and Indian regulatory requirements.

- Provide regulatory and quality leadership to ensure all products meet compliance with Indian laws and global standards.

- Drive the QRC strategic plan for India, aligning with business and global objectives.

Regulatory & Post-Market Vigilance (30%):

- Ensure all regulatory submissions, registrations, and filings are completed on time and in compliance with national and global requirements.

- Oversee post-market vigilance activities, including complaint handling, incident reporting, and corrective/preventive actions.

- Serve as the primary liaison with regulatory bodies including CDSCO, Ministry of Health & Family Welfare, Bureau of Indian Standards, and certification bodies such as TV SD.

People & Organizational Leadership (25%):

- Lead, mentor, and develop the QRC team, including managers and specialists.

- Foster a culture of accountability, collaboration, and continuous improvement.

- Retain and grow high-potential talent while ensuring team alignment with business goals.

Product Registration & Market Access (15%):

- Manage timely and compliant product registration processes to support market access.

- Anticipate regulatory changes and proactively develop strategies to ensure compliance readiness.

Internal & External Relationships:

- Internal: India Management Team, Regional QRC Teams, Business Area QRC Teams, Sales, Service, Logistics.

- External: CDSCO, BIS, ISO certification bodies, distributors, and other regulatory authorities.

Qualifications & Experience:

- Bachelor's degree in Engineering, Life Sciences, or a related field (advanced degree preferred).

- Minimum 10+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs, preferably in the medical device industry.

- Proven track record in building and scaling quality systems in compliance with FDA, EU, and Indian medical device regulations.

- Strong knowledge of QSR, QSIT, ISO standards, and international quality frameworks.

- Demonstrated experience in strategic planning, regulatory submissions, audits, and compliance oversight.

- Excellent leadership, influencing, and stakeholder management skills with the ability to operate effectively in a cross-functional global environment.

- Exceptional communication skills (written, verbal, and public speaking).

- Proficiency in MS Office and digital compliance tools.

(ref:iimjobs.com)

  • Mumbai, Maharashtra, India Getinge Full time

    Job Overview: The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He/ She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the...

  • Head of Compliance

    3 weeks ago


    Mumbai, Maharashtra, India Artha Group Full time

    About Artha Group Artha Group is a performance-led investment house managing over ₹1,250 crores (USD 150M+) across five fund platforms including Artha Venture Fund, Artha Select Fund, and Artha Continuum Fund. Our vertically integrated model spans venture capital, renewable energy assets, and global fund-of-fund structures. With 130+ investments and 30+...

  • Head of Compliance

    3 weeks ago


    Mumbai, Maharashtra, India Artha Group Full time

    About Artha Group Artha Group is a performance-led investment house managing over ₹1,250 crores (USD 150M+) across five fund platforms including Artha Venture Fund, Artha Select Fund, and Artha Continuum Fund. Our vertically integrated model spans venture capital, renewable energy assets, and global fund-of-fund structures. With 130+ investments and 30+...

  • Head of Compliance

    4 weeks ago


    Mumbai, Maharashtra, India Artha Group Full time

    About Artha GroupArtha Group is a performance-led investment house managing over ₹1,250 crores (USD 150M+) across five fund platforms including Artha Venture Fund, Artha Select Fund, and Artha Continuum Fund. Our vertically integrated model spans venture capital, renewable energy assets, and global fund-of-fund structures. With 130+ investments and 30+...


  • Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Job OverviewThe Head of Compliance is a critical role responsible for overseeing all compliance functions within the organization. This includes ensuring strict adherence to statutory and regulatory requirements, managing risk, and providing expert advice to the board of directors.This senior leadership position requires exceptional leadership, analytical,...


  • Mumbai, Maharashtra, India Artha Group Full time

    About Artha Group:- Artha Group is a performance-led investment house managing over - 1,250 crores (USD 150M+) across five fund platforms including Artha Venture Fund, Artha Select Fund, and Artha Continuum Fund.- Our vertically integrated model spans venture capital, renewable energy assets, and global fund-of-fund structures.- With 130+ investments and 30+...


  • Mumbai, Maharashtra, India Umedica Laboratories Private Limited Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Company DescriptionUMEDICA is part of the Amoli Group of Companies, specializing in the manufacture and export of a diverse range of pharmaceutical formulations including injectables, tablets, and capsules. Based in Vapi, Gujarat, our facility is approved by WHO GMP, US FDA, EU, Health Canada, and TGA among others. UMEDICA operates globally in over 85...


  • Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 4,00,000 - ₹ 8,00,000

    Job Title:">Senior Executive / Assistant Manager – Regulatory Affairs Full-time | Permanent Experience Required:">Chemicals | Pharmaceuticals | Food & BeveragesLegal | Quality Assurance | Regulatory Affairs We are seeking a Senior Executive / Assistant Manager – Regulatory Affairs to join our team in the chemicals and specialty ingredients sector.The...


  • Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

    Regulatory Compliance ExpertAbout the Role:We are seeking an experienced Regulatory Compliance Expert to join our team. In this role, you will be responsible for developing and implementing regulatory strategies to ensure compliance with all applicable laws and regulations in the construction industry.Key Responsibilities:Develop and implement regulatory...


  • Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 80,00,000 - ₹ 1,20,00,000

    Job Title: Regulatory Compliance SpecialistJob Overview:We are seeking a detail-oriented and proactive regulatory compliance specialist to join our fast-growing financial services organization.The role involves ensuring adherence to regulatory frameworks, conducting compliance monitoring, risk assessments, and assisting in audits.The ideal candidate should...