Job Title: Regulatory Affairs Officer
Department: Regulatory Affairs
Experience: 4+Years
Industry: Medical Devices (Orthopedic Implants preferred)
Location: Ahmedabad , Hathijan
Job Summary
Responsible for ensuring regulatory compliance of orthopedic medical devices as per CDSCO, MDR 2017, ISO 13485, and applicable international regulations. Prepare regulatory documentation, manage product registrations, and coordinate with internal teams and regulatory authorities.
Key Responsibilities
- Prepare and submit regulatory documents for product registrations and license renewals.
- Maintain Technical Files, DMF, PMF, Risk Management Files, and regulatory documentation.
- Ensure compliance with CDSCO, MDR 2017, ISO 13485, and other applicable regulations.
- Review product labeling, IFU, and packaging for regulatory compliance.
- Coordinate with QA, R&D, Production, and Marketing teams.
- Support internal/external audits and regulatory inspections.
- Monitor regulatory updates and implement compliance changes.
- Handle post-market surveillance, vigilance reporting, and change control activities.
Qualification
- Bachelor's degree in Pharmacy, Biomedical Engineering, Biotechnology, Life Sciences, or a related field.
Required Skills
- Knowledge of CDSCO, MDR 2017, ISO 13485, and medical device regulations.
- Experience in regulatory submissions and technical documentation.
- Strong documentation, communication, and coordination skills.
- Proficiency in MS Office.
Pay: ₹40,000.00 - ₹70,000.00 per month
Benefits:
- Food provided
- Provident Fund
Work Location: In person
