Manager, E.U. Medical Device & IVD Regulation

The role of Manager, E.U. Medical Device & IVD Regulation at Johnson & Johnson involves overseeing regulatory compliance for medical devices and in vitro diagnostics (IVD) within the European Union. Johnson & Johnson is a global leader in healthcare innovation, focusing on developing treatments for complex diseases and improving healthcare solutions through innovative medicine and MedTech. The main day-to-day responsibilities include monitoring and assessing new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) standards, conducting regulatory impact assessments, and ensuring compliance within the Clinical Quality Management System (QMS). The role also involves leading cross-functional projects, managing risk and compliance initiatives, and supporting audits and inspections. Additionally, the manager will drive updates to QMS processes, standard operating procedures (SOPs), training programs, and governance documentation to maintain ongoing compliance and inspection readiness. To qualify for this role, candidates must have a Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management, or a related field. An advanced degree is preferred. A minimum of five years of experience in pharmaceutical, medical device, diagnostics, biotechnology, or clinical research environments is required. Candidates must have expert knowledge of EU MDR, EU IVDR, and/or FDA medical device regulations, with practical application in clinical development or clinical research. Strong analytical, problem-solving, and communication skills are essential, along with proficiency in Microsoft Office applications. Nice-to-have skills include experience in medical device, IVD, companion diagnostics, software-enabled medical technologies, or combination product development. Knowledge of clinical trial, GCP, and ICH guidelines, as well as experience supporting health authority inspections, audits, and quality issue management activities, is also beneficial. Familiarity with digital tools, data-driven quality solutions, and intelligent automation approaches is a plus. The role is based in Beerse, Belgium; Allschwil, Switzerland; or Maidenhead, UK, and offers opportunities for growth and development within a global, inclusive work environment. What the role asks for: - Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management or a related field. - Minimum 5 years of experience in pharmaceutical, medical device, diagnostics, biotechnology or clinical research. - Expert knowledge of EU MDR, EU IVDR and/or FDA medical device regulations. - Proven ability to interpret regulations, conduct impact and gap assessments. - Strong analytical, problem-solving and partner management skills. - Excellent written and verbal communication skills. - Proficiency with Microsoft Office applications. - Nice-to-have: Experience in medical device, IVD, companion diagnostics, software-enabled medical technologies or combination product development.