EU Medical Devices & IVD Regulation Manager

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a Manager, EU Medical Devices & IVD Regulation in Beerse, Belgium, or Beerse, Switzerland or Maidenhead, UK. This role acts as the subject matter expert for EU MDR/IVDR, ensuring integration within the Clinical Quality Management System and guiding regulatory strategy for medical devices and diagnostics.

You will lead regulatory impact assessments, translate regulations into QMS controls, and support audits and continuous improvement across a

Qualifications

• Minimum 5 years of experience in pharmaceutical, medical device, diagnostics, biotechnology or clinical research environments.
• Experience in quality systems, regulatory compliance, clinical development or related functions.
• Expert knowledge of EU MDR, EU IVDR and/or FDA medical device regulations (including 21 CFR Subchapter H, Part 809 and 510(k)).
• Ability to interpret regulations, conduct impact and gap assessments, and translate requirements into QMS controls.
• Experience in leading cross-functional projects and managing risk, change and compliance initiatives.
• Excellent written and verbal communication skills; proficiency with MS Office.

Responsabilités

• Monitor and assess new EU MDR/IVDR regulations 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.
• Support audits, inspections, CAPAs and continuous improvement initiatives while finding opportunities for automation and operational excellence.

Connaissances

Regulatory compliance

EU MDR/IVDR

Quality systems

Clinical development

Cross-functional leadership

Regulatory inspections

Formation

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

Advanced degree preferred

Description du poste

Johnson & Johnson Innovative Medicine is seeking a Manager, EU Medical Devices & IVD Regulation in Beerse, Belgium, or Beerse, Switzerland or Maidenhead, UK. This role acts as the subject matter expert for EU MDR/IVDR, ensuring integration within the Clinical Quality Management System and guiding regulatory strategy for medical devices and diagnostics.

You will lead regulatory impact assessments, translate regulations into QMS controls, and support audits and continuous improvement across a