EU MDR/IVDR Regulatory Lead - MedDevices & IVD

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a Manager, EU Medical Devices & IVD Regulation to lead regulatory compliance within Clinical Development. This role can be located in Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK, and requires deep expertise in EU MDR/IVDR and related FDA regulations.

The position sits within the R&D Global Development organization, partnering with Quality, Regulatory Affairs and Clinical teams to shape QMS controls, SOPs and training across medical

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management or a related field required.
• Minimum 5 years of experience within pharmaceutical, medical device, diagnostics, biotechnology or clinical research environments.
• Experience in EU MDR, EU IVDR and/or FDA medical device regulations (including 21 CFR Subchapter H, Part 809 and 510(k)).
• Proven ability to interpret regulations, conduct impact and gap assessments, and translate requirements into QMS controls, procedures and training programmes.

Responsabilités

• 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.
• 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.

Connaissances

EU MDR/IVDR FDA regs

Regulatory impact assessments

QMS governance

Cross-functional leadership

Microsoft Office

Formation

Bachelor's degree in Life Sciences/Pharmacy/Engineering/Quality Management

Advanced degree preferred

Outils

Regulatory writing

Description du poste

Johnson & Johnson Innovative Medicine is seeking a Manager, EU Medical Devices & IVD Regulation to lead regulatory compliance within Clinical Development. This role can be located in Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK, and requires deep expertise in EU MDR/IVDR and related FDA regulations.

The position sits within the R&D Global Development organization, partnering with Quality, Regulatory Affairs and Clinical teams to shape QMS controls, SOPs and training across medical