Senior Regulatory Affairs Team Lead Medical Devices

4 weeks ago

Chennai, India Morulaa Healthtech Full time

Job Title: Senior Regulatory Affairs Team Lead Medical Devices

Location: Chennai, India

Department: Regulatory Affairs

Experience Required: Minimum 5 years

Reports To: Head of Regulatory Affairs / Director of Quality & Regulatory

Job Summary:

We are seeking a highly skilled and experienced Senior Regulatory Affairs Team Lead to manage and lead our regulatory submissions and strategy for medical devices in India. The ideal candidate will have a deep understanding of the regulatory framework governed by CDSCO (Central Drugs Standard Control Organization) and proven experience in successfully obtaining approvals for medical devices. This role requires both strategic oversight and hands-on execution, ensuring regulatory compliance and timely product registrations.

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: Bachelors or Masters 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.

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