EU Medical Devices & IVD Regulation Lead

Johnson Johnson; Beerse; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is recruiting a Manager for EU Medical Devices & IVD Regulation. Location options include Beerse, Belgium, with focus on regulatory compliance within Clinical Development and QMS frameworks.

The role requires 5+ years in pharma/medical devices, deep EU MDR/IVDR/FDA knowledge, and proven ability to lead cross-functional initiatives and drive regulatory excellence across a global organization.

Qualifications

• Minimum 5 years of experience in pharma, medical device, diagnostics, biotech or clinical research environments.
• Demonstrated expert knowledge of EU MDR, EU IVDR and/or FDA medical device regulations with practical application in development or clinical research.
• Ability to interpret regulations, perform impact and gap assessments and translate requirements into QMS controls.
• Experience leading cross-functional projects and managing risk, change and compliance in a regulated setting.
• Strong analytical, problem-solving and partner-management skills; excellent written and verbal communication; proficient with MS Office.

Responsabilités

• Monitor and assess new EU MDR/IVDR regulations and 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 to ensure ongoing compliance and inspection readiness.

Connaissances

Regulatory compliance

EU MDR/IVDR knowledge

Cross-functional collaboration

QMS controls

Risk assessment

Inspections/CapA

Communication skills

MS Office

Formation

Life Sciences

Pharmacy

Engineering

Quality Management

Description du poste

Johnson & Johnson Innovative Medicine is recruiting a Manager for EU Medical Devices & IVD Regulation. Location options include Beerse, Belgium, with focus on regulatory compliance within Clinical Development and QMS frameworks.

The role requires 5+ years in pharma/medical devices, deep EU MDR/IVDR/FDA knowledge, and proven ability to lead cross-functional initiatives and drive regulatory excellence across a global organization.