Job Title

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.

Job Details

• Type: 12 month, full time contract, starting ASAP.
• Location: Remote with occasional on-site presence in the north of England ideally.

Major Responsibilities

• Regulatory Strategy: Provide input into regulatory strategy for EU performance studies.
• Documentation: 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.
• Ethics Committee Submissions: Coordinate Ethics Committee (EC) submissions and approvals with NCA submissions, as required by country-specific processes.
• Regulatory Alignment: Support alignment of regulatory approaches with internal stakeholders and pharma partners.
• Regulatory Awareness: Maintain awareness of country specific NCA requirements and evolving submission process. Identify and implement new or updated regulatory requirements impacting the business.
• Standard Work: Develop and sustain scalable standard work supporting future high-volume submissions.
• Global Collaboration: Contribute to regulatory deliverables supporting global product development and lifecycle. Collaborate globally with Clinical Affairs, QA, R&D, Business Development and Product teams.
• Stakeholder Relationships: Establish strong relationships with internal and external stakeholders.