Senior Regulatory Affairs Specialist

EPM Scientific are partnered with a Global Diagnostics Manufacturer to hire a Sr. Regulatory Affairs Specialist primarily supporting Performance Study Applications for CDx programs to EU Competent Authorities and/or MHRA via CRO.

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:

• Provide input into regulatory strategy for EU performance studies
• Support the preparation, compilation, submission, and maintenance of performance study documentation in accordance with IVDR, including initial applications, amendments, notifications, reporting obligations, translations, payment and tracking responses to RFIs IDEs, Pre-submissions, PMA, 510k, IVDR Technical Files
• Coordinate Ethics Committee (EC) submissions and approvals with NCA submissions, as required by country-specific processes
• Support alignment of regulatory approaches with internal stakeholders and pharma partners
• Maintain awareness of country specific NCA requirements and evolving submission process. Identify and implement new or updated regulatory requirements impacting the business.
• Develop and sustain scalable standard work supporting future high-volume 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

• Regulatory Affairs
• IVDR
• Performance Studies
• Clinical Studies
• Diagnostics