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.
Positive 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.