S H PITKAR ORTHOTOOLS PVT. LTD.
Website:
pitkar.com
Job details:
Regulatory Affairs Officer
đź“Ť Location: Talegaon Dabhade, Maharashtra
🏠Industry: Medical Devices (Orthopedic Tools)
🏢 Company: S H Pitkar Orthotools Pvt. Ltd.
We are looking for a detail-oriented Regulatory Affairs professional with experience in medical device regulations to ensure compliance with applicable standards and support product approvals in domestic and international markets.
- Prepare, review, and maintain regulatory documentation for medical devices
- Ensure compliance with CDSCO, ISO 13485, and MDR requirements
- Handle product registration, licensing, and approvals
- Coordinate with internal departments (QA, Production, R&D) for regulatory compliance
- Manage technical files, device master files (DMF), and submissions
- Stay updated with changing regulatory guidelines and standards
- Support audits and inspections by regulatory authorities
- Strong knowledge of medical device regulations (India & Global)
- Understanding of ISO 13485, CE Marking, US FDA (preferred)
- Good documentation and communication skills
- Attention to detail and compliance mindset
- Bachelor’s degree in Biomedical / Mechanical / Life Sciences / Pharmacy
- 2–5 years of experience in Regulatory Affairs (Medical Devices preferred)
Interested can mail us CV pitkar.hr@gmail.com
Click on Apply to know more.