Manager, E.U. Medical Device & IVD Regulation

Biopharma Careers; Antwerpen; Hybride; EUR 120 000 - 180 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine seeks a Manager for EU Medical Devices & IVD Regulation. Located in Beerse, Belgium; or Allschwil, Switzerland; or Maidenhead, UK, the role leads regulatory compliance within Clinical Quality Management and coordinates with Regulatory, QA, and Clinical teams.

The position focuses on monitoring MDR/IVDR changes and implementing impact assessments, governance updates, and training to ensure inspection readiness and ongoing compliance.

Qualifications

• Experience navigating EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
• Strong understanding of clinical development, quality systems and regulatory submissions.
• Ability to collaborate with Regulatory, Quality, Legal and Clinical teams.

Responsabilités

• Monitor and interpret new EU MDR/IVDR regulations, standards and guidance.
• Lead regulatory impact assessments, gap analyses and risk evaluations.
• Serve as the primary R&D Quality lead for MDR/IVDR initiatives and drive governance documentation.

Connaissances

EU MDR/IVDR regulations

Regulatory strategy

QA/QMS

Cross-functional collaboration

Formation

Bachelor's or higher in Life Sciences or Regulatory Affairs

Outils

Regulatory databases

Description du poste

## About this opportunityAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.**Job Function:**R&D Operations**Job Sub Function:**Laboratory Operations**Job Category:**Professional**All Job Posting Locations:**Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom**Job Description:****Johnson & Johnson Innovative Medicine is recruiting for a Manager, EU Medical Devices & IVD Regulation!**Located in Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK!As a key member of the R&D Global Development organization, you will serve as the subject matter expert for EU Medical Device and In Vitro Diagnostic Regulations, ensuring their effective integration within the Clinical Quality Management System (QMS).In this highly visible global role, you will influence regulatory compliance strategies, lead complex regulatory impact assessments, and partner across Quality, Regulatory Affairs, Clinical Development, Medical Safety, Data Science and Therapeutic Areas to support innovative clinical research programs involving medical devices, diagnostics and combination products.This is an exciting opportunity to develop future regulatory compliance frameworks while driving process excellence and innovation across Johnson & Johnson's global clinical development organization!**Key Responsibilities**Monitor and assess new EU MDR/IVDR regulations, standards and guidance, evaluating their impact on Clinical Development and the Clinical QMS. Lead regulatory impact assessments, including gap analyses, risk evaluations and implementation strategies.Serve as the primary R&D Quality lead for assigned MDR/IVDR initiatives, partnering with Regulatory, Quality, Legal and business partners. Drive updates to QMS processes, SOPs, training programmes and governance documentation to ensure ongoing compliance and inspection readiness.