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.
This is a 12 month, full time contract, starting ASAP. 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 the following:
- 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.
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.
This is a 12 month, full time contract, starting ASAP. 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 the following:
- 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.
Desired Skills and Experience
EU IVDR, Diagnostics, Companion Diagnostics, 510k, FDA, PMA, Class C Diagnostics
#J-18808-Ljbffr
Principal Regulatory Affairs Specialist 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.
