EU MDR/IVDR Regulation Manager - Med Devices & IVD

Johnson & Johnson Innovative Medicine; High Wycombe; On-site; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine is seeking a Manager, EU Medical Devices & IVDR Regulation to serve as the SME for EU Medical Device and In Vitro Diagnostic Regulations.

Based in Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK, you will influence regulatory compliance strategies within the Clinical Quality Management System and partner across Regulatory Affairs, Quality, Clinical Development and more.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management or a related field is required (Advanced degree preferred).
• Minimum 5 years of experience in pharmaceutical, medical device, diagnostics, biotechnology or clinical research environments.

Responsibilities

• Monitor and assess new EU MDR/IVDR regulations, standards and guidance and evaluate impact on Clinical Development and QMS.
• Lead regulatory impact assessments, gap analyses, risk evaluations and implementation strategies.
• Drive updates to QMS processes, SOPs, training programmes and governance documentation to ensure ongoing compliance.

Skills

Regulatory expertise

Cross-functional collaboration

Analytical thinking

Regulatory strategy

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management or related field

Job description

Johnson & Johnson Innovative Medicine is seeking a Manager, EU Medical Devices & IVDR Regulation to serve as the SME for EU Medical Device and In Vitro Diagnostic Regulations.

Based in Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK, you will influence regulatory compliance strategies within the Clinical Quality Management System and partner across Regulatory Affairs, Quality, Clinical Development and more.