At a Glance
- Tasks: Lead regulatory strategies for medical devices and ensure compliance with global standards.
- Company: Global med-tech company focused on lifesaving innovations.
- Benefits: Competitive salary, bonus potential, hybrid work, and extensive personal development opportunities.
- Other info: Join a dynamic team and contribute to high-impact medical technologies.
- Why this job: Make a real impact in the medical field while advancing your career.
- Qualifications: 6+ years in Regulatory Affairs with strong EU MDR and US FDA experience.
The predicted salary is between 50000 - 55000 £ per year.
Are you an experienced Regulatory Affairs Specialist with a passion for medical devices? Do you have experience with 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 £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.
Please note that all applicants for this role should be able to prove that they are legally entitled to work in the UK.
Regulatory Affairs Lead in Crewe employer: Network Scientific Recruitment
Network Scientific is an excellent employer for those looking to kickstart their career in the environmental testing sector. Located in Didcot, Oxfordshire, we offer a supportive work culture that prioritises employee growth through comprehensive training and hands-on experience in analytical techniques. Our commitment to ethical practices and candidate care ensures that you will be part of a team that values your contributions and fosters a rewarding work environment.
Contact Details:
Network Scientific Recruitment Recruitment Team
