Manager, E.U. Medical Device & IVD Regulation

Location: Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK

Company

Johnson & Johnson Innovative Medicine develops medicines and healthcare solutions through science-based research and clinical development.

What you will do

• Monitor EU MDR and IVDR regulations, standards, and guidance and assess their impact on Clinical Development and the Clinical QMS.
• Lead regulatory impact assessments, gap analyses, risk evaluations, and implementation strategies.
• Act as the R&D Quality lead for MDR/IVDR initiatives and partner with Regulatory, Quality, Legal, Clinical Development, Medical Safety, Data Science, and Therapeutic Areas.
• Update QMS processes, SOPs, training programs, and governance documentation to maintain compliance and inspection readiness.
• Support audits, inspections, CAPAs, quality issue management, and continuous improvement initiatives.
• Identify opportunities for automation, data-driven quality solutions, and operational excellence.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Quality Management, or a related field; an advanced degree is preferred.
• At least 5 years of experience in pharmaceutical, medical device, diagnostics, biotechnology, clinical research, quality systems, regulatory compliance, or clinical development environments.
• Expert knowledge of EU MDR, EU IVDR, and/or FDA medical device regulations, including 21 CFR Subchapter H, Part 809, and 510(k).
• Experience interpreting regulations, conducting impact and gap assessments, and translating requirements into QMS controls, procedures, and training programs.
• Experience leading complex cross-functional projects and managing risk, change, and compliance initiatives in regulated environments.
• Strong analytical, problem-solving, communication, and partner management skills, with proficiency in Microsoft Office applications.

Nice to have

• Experience with medical devices, IVD, companion diagnostics, software-enabled medical technologies, or combination products.
• Clinical trial, GCP, ICH guideline, and risk-based quality management experience.
• Experience supporting health authority inspections, audits, CAPA programs, and quality issue management.
• Knowledge of digital tools, data-driven quality solutions, and intelligent automation.

Culture & Benefits

• Inclusive work environment focused on employee dignity, diversity, and merit.
• Annual bonus with a target based on pay grade and location.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Insurance plans, service anniversary awards, and recognition programs, subject to local plan terms.