Regulatory Affairs Sr. Coordinator

Role:
Support regulatory submissions and compliance for Orthopaedic implants and instruments across domestic and international markets. Act as a key contact for regulatory queries from internal teams, distributors, and consultants.

Responsibilities:

• Prepare regulatory dossiers for registrations, renewals, labelling, and tenders.

• Perform gap analysis and support CAPA and change control activities.

• Ensure product lifecycle compliance with EU MDR, FDA, and CDSCO requirements.

• Coordinate regulatory documentation and maintain compliance records.

Skills:

• Strong knowledge of EU MDR, FDA 21 CFR, CDSCO, ISO 13485, ISO 14971.

• Experience with global submissions preferred; strong English communication skills.