Quality Assurance Regulatory Lead
4 days ago
Job Overview
We are seeking a highly motivated Quality Assurance Regulatory Lead to join our Quality Assurance team at Dozee. As a key member of our Quality Assurance department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.
About the Role
This is a fantastic opportunity for an experienced professional to leverage their knowledge and expertise in medical device regulation to drive quality and compliance within our organization. The successful candidate will have a strong background in regulatory affairs, excellent analytical skills, and the ability to communicate complex information effectively.
Responsibilities
- Leverage knowledge and expertise in medical device regulation to drive quality and compliance within the organization.
- Develop and implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA, and CE Marking.
- Collaborate with cross-functional teams to ensure quality and regulatory requirements are successfully implemented and maintained.
- Provide guidance to the team on interpreting regulatory requirements for various life-cycle stages of projects.
- 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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