Medical Device Regulatory Lead

4 weeks ago

India ArtiXio Full time

About the Role

We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other global regulatory agencies. This role requires leadership, ownership, and the ability to guide cross-functional teams through complex regulatory pathways.

Key Responsibilities

  • Lead the preparation, submission, and management of medical device applications (US FDA 510k, CE Marking, MDSAP, CDSCO, and other markets).
  • Ensure compliance with regulatory standards including ISO 13485, 21 CFR 820 , and other applicable regulations.
  • Act as the primary contact for Health Authorities, managing queries and responses effectively.
  • Oversee regulatory strategy, project planning, and execution for medical device submissions.
  • Provide guidance on Quality Management Systems (QMS) and support audits/inspections.
  • Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Clinical, Commercial) to align regulatory requirements with business objectives.
  • Take ownership of projects, demonstrating leadership and accountability in delivery.

Qualifications

  • 4–6 years of experience in medical device regulatory affairs .
  • Proven track record with submissions to FDA (510k), CE Marking, CDSCO, and other agencies .
  • Strong knowledge of ISO 13485, 21 CFR 820, QMS practices, and international medical device regulations .
  • Experience in responding to Health Authority queries and managing regulatory communications.
  • Excellent project management, organizational, and leadership skills.
  • Ability to work independently, take ownership, and drive results.

Why Join Us

  • Opportunity to lead regulatory projects across global markets.
  • Work in a dynamic, entrepreneurial, and collaborative environment.
  • Be at the forefront of advancing compliance and patient safety in medical devices.
  • Apply now via LinkedIn or connect with us to explore this opportunity

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