Medical Device Regulatory Lead

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

Why Join Us