EPM Scientific is hiring a Principal Regulatory Affairs Specialist to lead regulatory activities for CDx devices, including FDA PMA and EU IVDR submissions, for Class III/Class C products. The role involves coordinating global submissions, interacting with Notified Bodies and authorities, and guiding cross-functional teams.
The contract is 12 months, full-time with remote work and occasional on-site presence in the north of England.
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Principal Regulatory Lead, CDx PMA/EU IVDR - Remote employer: EPM Scientific
As a Senior Quality Engineer in Belfast, you will join a dynamic team dedicated to excellence in the medical devices sector. Our company fosters a collaborative work culture that prioritises employee growth through continuous learning and development opportunities, ensuring you can thrive in your role. With a commitment to quality and innovation, we offer a supportive environment where your contributions directly impact our integration programme and overall success.