EU Medical Device & IVD Regulation Lead

J&J Family of Companies; Beerse; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Well-being reimbursement

Résumé du poste

Johnson & Johnson Innovative Medicine is recruiting for a Manager, EU Medical Devices & IVD Regulation, located in Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK. You will serve as the subject matter expert for EU MDR/IVDR and ensure integration within the Clinical Quality Management System.

You will influence regulatory compliance strategies, lead complex regulatory assessments, and partner across Quality, Regulatory Affairs, Clinical Development and more to support

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering or related field is required.
• Minimum 5 years of experience in pharmaceutical, medical device, diagnostics or clinical research environments.
• Expert knowledge of EU MDR/IVDR and/or FDA medical device regulations with clinical development experience.
• Ability to translate regulations into effective QMS controls, procedures and training.

Responsabilités

• Monitor EU MDR/IVDR developments and assess their impact on Clinical Development and the Clinical QMS.
• Lead regulatory impact assessments, gap analyses, risk evaluations and implementation strategies.
• Drive updates to QMS processes, SOPs, training programmes and governance documentation; support audits and inspections.

Connaissances

Regulatory strategy

Regulatory impact assessment

Cross-functional collaboration

QMS documentation

Audit support

Formation

Bachelor's degree in Life Sciences, Pharmacy, Engineering

Outils

Microsoft Office

Description du poste

Johnson & Johnson Innovative Medicine is recruiting for a Manager, EU Medical Devices & IVD Regulation, located in Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK. You will serve as the subject matter expert for EU MDR/IVDR and ensure integration within the Clinical Quality Management System.

You will influence regulatory compliance strategies, lead complex regulatory assessments, and partner across Quality, Regulatory Affairs, Clinical Development and more to support