Manager, E.U. Medical Device & IVD Regulation

Johnson & Johnson · Antwerp, Belgium +2 more

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Role summary

Johnson & Johnson seeks a regulatory affairs manager to serve as subject matter expert for EU medical device and in vitro diagnostic regulations within the clinical quality management system. The role involves monitoring regulatory changes, leading impact assessments, and partnering across global functions to ensure compliance in clinical development programs.

What they're looking for

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management, or related field
Minimum 5 years in pharmaceutical, medical device, diagnostics, biotechnology, or clinical research
Expert knowledge of EU MDR, EU IVDR, and FDA medical device regulations with practical application
Demonstrated ability to interpret regulations and conduct gap and impact assessments
Experience leading complex cross-functional projects in regulated environments
Strong analytical, problem-solving, and cross-functional influence skills
Proficiency with Microsoft Office and excellent written and verbal communication

What you'll be doing

Monitor and assess new EU MDR/IVDR regulations, standards, and guidance for clinical development impact
Lead regulatory impact assessments, gap analyses, risk evaluations, and implementation strategies
Drive updates to QMS processes, SOPs, training programs, and governance documentation for compliance
Partner with Regulatory Affairs, Quality, Legal, and business teams on MDR/IVDR initiatives
Support audits, inspections, CAPAs, and identify opportunities for process automation and improvement

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Date posted5 days ago

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