EPM Scientific
Principal Regulatory Affairs Specialist
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EPM Scientific and Global Diagnostics Manufacturer Partnership
EPM Scientific are partnered with a Global Diagnostics Manufacturer to hire a Principal Regulatory Affairs Specialist supporting FDA PMA/EU IVDR submissions for Class III/Class C CDx devices.
Job Details
- Duration: 12 months, full time contract, starting ASAP
- Location: Remote with occasional on site presence in the north of England ideally
Major Responsibilities
- Responsible for planning, organizing, and conducting activities related to assigned areas of the site's regulatory obligations, including:
- Serve as Core Team RA lead on CDx new product development team
- Lead the compilation of technical files to support regulatory submissions globally, including FDA Class III PMA, EU Class C CDx submissions to Notified Body/European Medicines Agency
- Communicate and negotiate with global regulatory authorities to meet business goals and regulatory milestones
- Support alignment of regulatory approaches with internal stakeholders
- Maintain awareness of country specific regulatory requirements and evolving submission processes. Identify and implement new or updated regulatory requirements impacting the business
- Develop and sustain scalable standard work supporting future submissions
- Contribute to regulatory deliverables supporting global product development and lifecycle
- Collaborate globally with Clinical Affairs, QA, R&D, Business Development, and Product teams
- Establish strong relationships with internal and external stakeholders
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- EU IVDR
- Diagnostics
- Companion Diagnostics
- 510k
- FDA
- PMA
- Class C Diagnostics
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