Regulatory Affairs Lead

Network Scientific Recruitment; Crewe; Hybrid; GBP 50,000 - 60,000; Full time

Benefits offered by this job

Performance bonus

Training opportunities

Hybrid work

Job summary

Network Scientific Recruitment partners with a global med-tech company with Crewe offices to recruit a Senior Regulatory Affairs Specialist. The role defines and leads regulatory strategies for assigned portfolios, guiding EU MDR and US FDA submissions (510(k)) to ensure compliance and market access.

The successful candidate will interpret global regulatory requirements, leverage risk management (ISO14971), and drive regulatory leadership across projects.

Qualifications

• 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 ISO14971 Risk Management within a Medical Device industry desirable

Responsibilities

• 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

Skills

Regulatory strategy

EU MDR (2017/745)

510(k) submissions

QSMR / QSR knowledge

Technical Documentation

Regulatory leadership

ISO14971 risk management

Education

Degree in life sciences / engineering or related field

Job description

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 Overview

• 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

Requirements

• 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 ISO14971 Risk Management within a Medical Device industry desirable

In return

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 £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.

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