Medical Device Compliance Manager
6 days ago
Job Summary
We are seeking an experienced Medical Device Compliance Manager to join our Quality Assurance team at Dozee. This is a challenging opportunity for a professional with a strong background in medical device regulation to drive quality and compliance within our organization.
About the Role
The successful candidate will have a deep understanding of regulatory requirements and be able to develop effective strategies for maintaining compliance. They will work closely with cross-functional teams to ensure quality and regulatory requirements are successfully implemented and maintained.
Responsibilities
- Develop and implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA, and CE Marking.
- Collaborate with product development and transfer teams to ensure regulatory requirements are met.
- Analyze and interpret standards, technical procedures, professional journals, and governmental guidance and regulation documents.
- Prepare dossiers and device master files for regulatory submissions.
- Drive good documentation practices and ensure adherence to standard processes.
Requirements
- B.Tech degree in a relevant field.
- A minimum of 3-5 years of experience in medical device regulation.
- Experience with international medical device regulatory approvals and submissions.
- Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System, and ISO 14971 Risk Management for Medical Devices.
- Ability to analyze and interpret standards, technical procedures, professional journals, and governmental guidance and regulation documents.
What We Offer
The salary range for this position is $120,000 - $180,000 per year, depending on qualifications and experience. We offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
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