Regulatory Affairs Lead

About the role

We are seeking an experienced Regulatory Affairs Lead to join a global med‑tech client based in Crewe. You will shape and execute regulatory strategies for medical device portfolios, ensuring market access across Europe and the United States.

Key responsibilities

• Define and lead regulatory strategies aligned with business objectives.
• Prepare, review and submit EU Technical Documentation, US 510(k) and other global applications.
• Interpret and apply EU MDR and US FDA QSMR requirements.
• Lead the development of regulatory risk assessments and ISO 14971 risk management files.
• Collaborate with cross‑functional teams to support product development and launch.

Required profile

• Degree or equivalent in life sciences, engineering, pharmaceuticals or related field.
• Minimum 6 years of regulatory affairs experience in medical devices, biologics or combination products.
• Proven experience with EU MDR (2017/745) and US FDA QSR/QSMR, including technical documentation and 510(k) submissions.
• Strong understanding of ISO 14971 risk management.

Required skills

• EU MDR compliance
• US FDA QSR / QSMR knowledge
• Technical Documentation preparation
• 510(k) submission expertise
• ISO 14971 risk management

What we offer

• Competitive salary £50,000‑£55,000 per year plus performance bonus.
• Hybrid working model (2 days remote per week).
• Extensive personal development programme and training.
• Opportunity to work on high‑impact medical devices.