About the job

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.

• Role OverviewPermanent, 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

• RequirementsDegree 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 ISO14971 Risk Management within a Medical Device industry desirable

• In returnThis 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 £60,000 (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.