Regulatory Affairs Lead

Are you an experienced Regulatory Affairs Specialist with a passion for medical devices? Do you have experience EU MDR and US FDA QSMR?

We are working with a well-established, global med-tech company, with offices in Crewe, who specialise in the development and advancement of lifesaving medical technologies and innovations used within a wide range of areas.

• Permanent, Full-time
• Define and lead regulatory strategies for assigned portfolios, ensuring alignment with business objectives and market access plans
• Lead the preparation, review and submission of regulatory applications (including EU Technical Documentation, US 510(k), and other global submissions) ensuring submissions are compliant, robust, and aligned with current regulatory expectations
• Interpret and apply global regulatory requirements, particularly EU MDR and DA QSMR

• Degree or equivalent in life sciences, pharmaceuticals, engineering, or related disciplines
• Minimum 6 years’ experience in Regulatory affairs (medical devices, biologics, pharmaceuticals, combination products)
• Strong experience with EU MDR (2017/745) and US FDA QSR (now QSMR) including Technical Documentation and 510ks
• Experience leading regulatory strategy development
• Understanding of ISO
  14971 Risk Management within a Medical Device industry desirable

This is a fantastic opportunity for a Senior Regulatory Affairs Specialist to progress your career working on a high-impact device. Our client is offering a competitive starting salary between £50,000 and £55,000 (with a bonus based on company and individual performance). You will also receive an extensive personal development programme and training opportunities. This role is also hybrid with 2 days work from home.

For more information, please contact Liam Daly.

Please note that all applicants for this role should be able to prove that they are legally entitled to work in the UK.