Senior Regulatory Affairs Specialist (IVDR / CDx Performance Studies)
Location: Warrington/UK-based (Remote or Hybrid)
Contract: 12 months
Hours: 37.5 per week, Monday-Friday (flexible)
Start date: ASAP
Rate: £80 per hour
This is an excellent opportunity for an experienced regulatory professional to take the lead on high‑impact EU Member State notification activities for performance studies relating to Companion Diagnostics under the IVDR. You will play a key role in shaping regulatory strategies, driving timely submission packages, and ensuring the successful execution of complex regulatory interactions across Europe.
About the Role
In this senior position, you will oversee the preparation, coordination, and delivery of regulatory submissions for IVDR CDx performance studies involving leftover samples. You will act as the primary point of contact for EU Competent Authorities and Ethics Committees, ensuring compliance with regulatory frameworks while supporting strategic project objectives.
You will work cross‑functionally with Clinical, Medical, Legal, Quality, and Project Management teams across a highly international environment. This role can be performed remotely or as part of a hybrid arrangement within the UK and may involve occasional European travel.
Key Responsibilities
Lead EU Member State notification activities for IVDR CDx performance studies.
Prepare, compile, review, and submit regulatory documentation to EU Competent Authorities and/or Ethics Committees.
Coordinate cross‑functionally to ensure timely and compliant submissions across multiple regions.
Act as the main point of contact for regulatory authorities and ethics bodies, responding to queries and requests for additional information.
Maintain accurate records of submissions, correspondence, approvals, and supporting documentation in line with internal quality systems.
Provide regulatory input to CDx project teams related to study design, documentation, and compliance requirements.
Minimum Qualifications
Bachelor's degree in Life Sciences, Biomedical Sciences, or a related scientific field.
At least 3 years' experience in Regulatory Affairs, Clinical Regulatory, or a related discipline within the IVD, medical device, or pharmaceutical sectors.
Strong experience with EU regulatory submissions and interactions with Competent Authorities and/or Ethics Committees.
Good knowledge of IVDR (EU 2017/746), particularly regarding performance studies.
Proven ability to manage multiple submissions simultaneously across different EU Member States.
Excellent written and verbal English communication skills.
Skills and Attributes
High energy level with a positive, action‑oriented approach.
Ability to work autonomously in a matrix‑managed global organisation.
Strong problem‑solving capability based on regulatory and industry knowledge.
Ability to operate effectively under tight timelines across multiple regions.
Willingness to travel (approximately 10-15%).
Strong digital and PC‑based documentation skills.
Why Apply?
Opportunity to lead complex IVDR regulatory activities at a senior level.
Exposure to cross‑functional global teams and high‑visibility CDx projects.
Flexible working arrangement, fully remote or hybrid within the UK.
Competitive day rate and a full year of contract stability.
High-impact role supporting crucial performance study activities across Europe.
How to Apply
If you're an experienced regulatory professional ready to take on a senior role supporting Companion Diagnostics and IVDR performance studies across Europe, we'd be happy to hear from you.
Submit your application and take your next step in shaping regulatory excellence across the EMEA region.
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