Regulatory Affairs Manager - IVDs

About the Position

We are seeking a Regulatory Affairs Manager - IVDs to join our team in London, UK. This role involves managing IVD performance study notifications and applications in accordance with EU IVDR.

Responsibilities

• Lead operational planning of IVD performance study notifications/applications activities.
• Coordinate cross-functional activities required for performance study notifications/applications milestones, trackers, request for information, and risk mitigation plans.
• Ensure timely responses to regulatory authority requests for information.
• Facilitate communication between performance study sponsors, clinical study teams, and regulatory stakeholders.
• Track country-specific submission requirements and maintain submission status trackers.
• Contribute to continuous improvement focused on submission planning, tracking, and operational efficiency.

Requirements

• Minimal Requirements

  • Bachelor's degree in Life Sciences, Engineering, or related technical field.
  • 5+ years’ pharmaceutical or diagnostics industry experience including 1-2 years IVD/Medical Device Regulatory Affairs experience.
  • Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA).
  • Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs.
  • Excellent written and verbal communication skills.

• Preferred Requirements

  • Advanced degree (Masters and above).
  • Experience with companion diagnostic development processes and regulatory filings.

We Offer

• Competitive salary range: £60,000 - £76,000.
• Maternity Cover – 12 Month Contract.
• Hybrid/Remote working arrangement based in West London, UK.

About the Company

Cpl Life Sciences is partnering with a global leading biotechnology business at the heart of innovation. This role is sitting at the interface of therapeutics and diagnostics, helping bring biomarker-driven medicines to market through companion diagnostic and IVD regulatory strategy.