Regulatory Affairs Officer

Regulatory Affairs Officer

S H Pitkar Orthotools Pvt. Ltd.

Talegaon Dabhade

Regulatory Affairs

The Regulatory Affairs Officer will be responsible for handling regulatory documentation, compliance activities, product registrations, and coordination with regulatory authorities for medical device products. The candidate will ensure compliance with applicable regulatory standards and maintain all statutory records and approvals.

• Prepare and maintain regulatory documentation for medical devices.
• Handle product registration, license renewals, and compliance submissions.
• Coordinate with regulatory authorities and certification agencies.
• Ensure compliance with ISO, CDSCO, MDR, FDA, CE, and other applicable standards.
• Review product labels, IFU, packaging, and technical documents.
• Support internal and external audits.
• Maintain records of certificates, approvals, and licenses.
• Coordinate with QA, Production, Purchase, and R&D departments for compliance requirements.
• Monitor updates in regulatory guidelines and implement necessary changes.
• Prepare SOPs, declarations, technical files, and compliance reports.
• Ensure timely submission of statutory and customer-required documents.

• Knowledge of medical device regulatory requirements.
• Good documentation and communication skills.
• Knowledge of ISO 13485, CDSCO, CE, FDA, or MDR regulations preferred.
• Proficiency in MS Office (Excel, Word, Outlook).
• Strong analytical and coordination skills.
• Attention to detail and compliance management.

Bachelor’s Degree in Pharmacy, /Diploma or Certification in:

• Regulatory Affairs
• Medical Device Regulations
• ISO 13485
• GMP Documentation
• CDSCO / FDA / CE Compliance

• 3 to 6 years of experience in Regulatory Affairs / QA for Medical Devices.
• Freshers with relevant knowledge can also apply.

• Experience in handling regulatory audits and documentation.
• Good understanding of medical device compliance procedures.
• Ability to coordinate with multiple departments and external agencies.
• Good organizational and time management skills.