Regulatory Compliance Expert
6 hours ago
About the Role:
Dozee is seeking a highly skilled Regulatory Compliance Expert - Medical Devices to join our team. As a Regulatory Compliance Expert, you will be responsible for ensuring that our medical devices meet regulatory requirements. This includes planning, establishing, and maintaining a Quality Management System (QMS) in accordance with EN ISO 13485, 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.
We offer a competitive salary range of $80,000 - $120,000 per annum, depending on experience, and a comprehensive benefits package including health insurance, retirement savings plan, and paid time off. 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.
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