Regulatory Affairs Specialist

Job Purpose:

To lead regulatory submissions and compliance activities for cardiovascular medical devices, specifically drug‑eluting stents, balloon catheters, and related vascular devices. Ensure adherence to Indian Medical Device Rules (MDR 2017), ISO 13485, and EU MDR.

Key Responsibilities:

• Prepare and submit regulatory applications for stents and catheter systems (CDSCO Forms MD‑5/6/7/8/14/15/16)

• Compile and manage technical documentation, DMF, STED (Summary Technical Documentation), CER (Clinical Evaluation Report), RMR (Risk Management Report), Biocompatibility records, Animal Study Reports.

• Ensure compliance with MDR‑2017, EU MDR 2017/745 and applicable ISO standards (ISO 25539, ISO 10993, etc.)

• Maintain CDSCO manufacturing/import licenses, QMS certificates, Notified Body certifications

• Review IFU, labelling, packaging artwork claims

• Handle regulatory change control for product and process modifications

• Liaise with CDSCO, notified bodies, regulatory consultants, test labs (chemical, mechanical, biocompatibility, stability)

• Assist in vigilance reporting, and field corrective action

• Maintain UDI compliance & track PMS reports and risk management documentation (ISO 14971)

• Support internal, customer, and notified body audits.