EU MDR/IVDR Regulatory Lead - Medical Devices & IVD

Johnson & Johnson Innovation; Antwerpen; Sur place; EUR 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Career development programs

Résumé du poste

Johnson & Johnson Innovation seeks a Manager for EU Medical Devices & IVD Regulation to join the R&D Global Development team. Location options include Beerse (Belgium), Allschwil (Switzerland), or Maidenhead (UK).

You will serve as the SME for EU MDR/IVDR within the Clinical QMS and influence regulatory compliance strategies across functions. You will drive regulatory impact assessments, lead cross‑functional projects, and help shape global frameworks for devices, diagnostics and combination

Qualifications

• Bachelor's degree in Life Sciences or related field required. Advanced degree preferred.
• Minimum 5 years' experience in pharmaceutical/medical device regulatory/clinical development.
• Proven ability to interpret regulations and translate into QMS controls and training.

Responsabilités

• Monitor EU MDR/IVDR regulations and assess impact on Clinical Development and QMS.
• Lead regulatory impact assessments, gap analyses and risk evaluations.
• Partner with Regulatory, Quality, Legal and business teams to support compliance initiatives.

Connaissances

EU MDR/IVDR knowledge

Cross-functional collaboration

Regulatory strategy

Regulatory submissions

Quality systems

Formation

Bachelor's degree in Life Sciences or related

Description du poste

Johnson & Johnson Innovation seeks a Manager for EU Medical Devices & IVD Regulation to join the R&D Global Development team. Location options include Beerse (Belgium), Allschwil (Switzerland), or Maidenhead (UK).

You will serve as the SME for EU MDR/IVDR within the Clinical QMS and influence regulatory compliance strategies across functions. You will drive regulatory impact assessments, lead cross‑functional projects, and help shape global frameworks for devices, diagnostics and combination