Senior Regulatory Affairs Team Lead Medical Devices

Job Title: Senior Regulatory Affairs Team Lead Medical Devices

Location:

Department:

Experience Required:

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Job Summary:

Senior Regulatory Affairs Team Lead

Key Responsibilities:

• Lead Regulatory Submissions:

  Drive end-to-end regulatory submissions to CDSCO for new product approvals, including Class A, B, C, and D medical devices.

• Dossier Preparation:

  Oversee the compilation, review, and submission of Device Master Files (DMFs), Plant Master Files (PMFs), and other required documentation.

• Liaison with CDSCO:

  Serve as the primary point of contact with CDSCO officials, Notified Bodies, and authorized agents.

• Regulatory Strategy:

  Develop and implement regulatory strategies for both new and existing product lines, ensuring alignment with local and international regulatory standards.

• Team Leadership:

  Manage and mentor a team of regulatory associates/specialists; provide guidance on technical file preparation, regulatory pathways, and compliance.

• Audit Support:

  Participate in internal and external audits (CDSCO, ISO 13485, MDSAP), including responding to observations and ensuring closure of compliance gaps.

• Monitoring & Intelligence:

  Stay current with CDSCO regulations, guidance documents, and global regulatory trends; disseminate regulatory intelligence to internal teams.

• Cross-functional Collaboration:

  Work closely with R&D, QA, Marketing, and Supply Chain to ensure regulatory requirements are incorporated throughout the product lifecycle.

Requirements:

• Education:

  Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.

• Experience:

  Minimum

  5 years

  of hands-on regulatory experience with medical device registrations in India, with a focus on

  CDSCO Class C & D devices

  preferred.

• Regulatory Knowledge:

  Strong understanding of the Indian Medical Device Rules (MDR), 2017 and CDSCO’s submission pathways (Form MD-14/15, MD-16/17, MD-9/10, etc.).

• Technical Skills:

  Experience preparing technical documentation (CE, 510(k), or other global dossiers is a plus).

• Soft Skills:

  Excellent communication, leadership, problem-solving, and project management skills.

• Certifications (preferred):

  RAC (Regulatory Affairs Certification), ISO 13485 knowledge, or equivalent certifications.