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:

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

  
  


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  Perform gap analysis and support CAPA and change control activities.

  
  


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

  
  


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  Coordinate regulatory documentation and maintain compliance records.

  
  

Skills:

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

  
  


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  Experience with global submissions preferred; strong English communication skills.

  
  
Full-time Business Operations Specialists