Job Description
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.