Regulatory Affairs Executive

Allwin Medical Devices is a leading manufacturer of a wide range of medical devices, including Women's Health (IVF), Urology, Gastroenterology, and Interventional Radiology. The company, headquartered in Anaheim, California, is committed to providing its customers with high-quality devices at affordable prices. Our founders have more than 30 years of combined experience in the medical device industry.

For more details, kindly visit: allwinmedical.com

Designation: Regulatory and Affair

Qualification: B.Tech, B. Pharma or related degree.

Location: Mumbai

Description

• Prepare and maintain EU MDR Technical Files and supporting documentation.
• Handle CE Marking and EU MDR regulatory requirements.
• Prepare and review Technical Documentation, Risk Management Files, Clinical Evaluation, PMS & PMCF documents.
• Coordinate with Notified Bodies for technical file submissions, audits, and queries.
• Ensure compliance with ISO 13485, EU MDR 2017/745 and applicable regulatory requirements.
• Support product registrations and regulatory submissions in international markets.
• Review and maintain Declarations of Conformity, labels, IFUs and product documentation.
• Manage regulatory changes, document updates, and change-control activities.
• Coordinate with QA, R&D, Production and Clinical teams for regulatory documentation.
• Maintain regulatory records and ensure timely submission of required documents.

Experience & Skills:

• 2–5 years of experience in Regulatory Affairs in Medical Devices.
• Hands-on experience in EU MDR Technical File preparation is essential.
• Good knowledge of EU MDR 2017/745, ISO 13485 and Risk Management (ISO 14971).
• Experience in technical documentation and regulatory submissions.
• Good documentation, coordination and communication skills.