Medical Device Regulatory Affairs Specialist

3 hours ago


Bengaluru, Karnataka, India Dozee Full time

Job Description:

As a Medical Device Regulatory Affairs Specialist at Dozee, you will play a pivotal role in ensuring the company's products meet regulatory requirements. Your primary responsibility will be to plan, establish, and maintain a Quality Management System (QMS) in accordance with EN ISO 13485. This involves implementing regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA, and CE Marking.

Your key responsibilities will include preparing dossiers and device master files for regulatory submissions, following the Medical Device Act by CDSCO and other relevant regulations related to products developed, and providing directions for compliance to the organization. You will also work with different teams to set up Quality policies and standards, ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control, and ISO Standards.

In addition, you will train and ensure all assigned employees are aware of and comply with company policies, government procedures, and regulations. You will also work closely with product development and product transfer teams, conduct supplier audits and qualifications, and assist with Management Review meetings including generation of quality metrics and coordinating the review.

The ideal candidate should have a B.Tech degree and minimum 3-5 years of experience in Medical Device Regulation. They should have experience with international medical device regulatory approvals and submissions, supporting regulatory agency inspections and Notified Body Audits in an SME role, and demonstrated knowledge of US FDA, EU MDR, ISO 13485 QMS, and ISO 14971 Risk Management for Medical Devices as well as IEC 62304. The ability to analyze and interpret standards, technical procedures, professional journals, and governmental guidance and regulation documents is essential.



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