Medical Device Regulatory Lead

About the Role

We are looking for a Medical Device Regulatory Lead

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