Associate Director Global Regulatory Affairs - Medical Devices, CDx / IVDs

Reference: Oli10544

Expiry Date: 05-11-2021

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

Associate Director Global Regulatory Affairs - Medical Devices, CDx / IVDs

We are hiring for an Associate Director Global Regulatory Affairs - Companion Diagnostics, to join a growing bio-pharmaceutical company based in the M4 Corridor of Greater London.

If you are looking for an existing professional challenge, that would give you the opportunity to grow alongside and expanding, mid-size Biotech, then this role may be the one for you. Our client is looking for a medical devices regulatory professional with CDx / IVDs experience as well as IVDR. This company has 4-5 CDx development programs running as well as other in early development, designed to support a rich pipeline with multiple BLA/MAAs planned in the next several years.

You will consider this role if:

  • You have worked with a leading CDx Vendor on IVDs used by Drug Developers as Companion or Complimentary Diagnostics and you have been either in a regulatory or combined RA/QA role


  • You are working in a CDx team in a pharmaceutical or biotech company, and want to advance through the grades, in an organization which is merit-based and pays their regulatory folks in devices the same they pay their folks in drug development!


  • You are happy to stay in place and relocate to site when Covid allows (the company have a Digital Hiring and On Boarding process, so no need to delay!)
  • You have the type of personality people are attracted to professionally, you know how to educate drug development regulatory and project teams on the CDx regulatory pathway from identification of the Biomarkers to the actual IVD being registered as a CDx
  • You want to be rewarded for and accountable for your deliverables, reaching the key milestones, and have co-managed CDx registrations (this could be at arms’ length via the vendor).

Responsibilities will include:

  • Leading CDx regulatory activities for IVD products in the EU and US, and also supporting local regulatory activities in other regions such us China
  • Responsible for the development and implementation of regional and global IVD regulatory strategy supporting the portfolio
  • Providing medical device regulatory guidance to the drug development and launch program teams
  • Responsible and leading all Health Authority and Notified Bodies interactions on CDx matters in all regions
  • Planning and preparation of devices documentation as well as review and approval of third party documentation for in order to achieve timely approvals.

This role can be based in one of several locations – M4 Corridor of Grater London, UK as well as Belgium and the East Coast, US. The company offers a relocation package for those willing to relocate.

Interested in the above? I look forward to hearing from you!

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Matt Greig on +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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