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Senior/Regulatory Consultant IVDR

Central London   •  Negotiable  •  Permanent, Full time


Senior/Regulatory Consultant IVDR

Fully homebased

United Kingdom

Attractive salary + package

A Regulatory Affairs Senior Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.

Responsibilities:

- Study Risk Determinations

- Regulatory strategy assessments for diagnostic partnerships, commercial launches

- Regulatory strategy for biomarkers in clinical studies

- Leadership of engagements with FDA and other regulators as required to confirm acceptability of regulatory strategy

- Collaboration with diagnostic partners to facilitate Dx labels, regulator questions, etc.

- Communication of regulatory strategies and risks via team meetings, written communications, etc.

Ideal candidate will possess:

- BA/BS in scientific or technical discipline or advanced degree

- Companion Diagnostic regulatory experience (either Dx or pharma side)

- IVD regulatory experience, including understanding of IVDR (EU)

- Understanding of CAP/CLIA and Laboratory Developed Tests (US)

- Preferred: knowledge of international regulations for IVDs, including China and Australia

- Project management skills

- Fluent English

  • Agency: Cpl Life Sciences
  • Contact: Ed Taylor
  • Reference: JO-2201-483650
  • Posted: 14th January 2022
  • Expires: 11th February 2022

Cpl Life Sciences

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