Johnson & Johnson Innovative Medicine
Manager, E.U. Medical Device & IVD Regulation
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: R&D Operations
Job Sub Function: Laboratory Operations
Job Category: Professional
All Job Posting Locations:
- Allschwil, Basel-Country, Switzerland
- Beerse, Antwerp, Belgium
- High Wycombe, Buckinghamshire, United Kingdom
Job Description:
Johnson & Johnson Innovative Medicine is recruiting for a Manager, EU Medical Devices & IVD Regulation!
Locations: Beerse, Belgium; Allschwil, Switzerland; Maidenhead, UK
As a key member of the R&D Global Development organization, you will serve as the subject matter expert for EU Medical Device and In Vitro Diagnostic Regulations, ensuring their effective integration within the Clinical Quality Management System (QMS).
In this highly visible global role, you will influence regulatory compliance strategies, lead complex regulatory impact assessments, and partner across Quality, Regulatory Affairs, Clinical Development, Medical Safety, Data Science, and Therapeutic Areas to support innovative clinical research programs involving medical devices, diagnostics, and combination products.
This is an exciting opportunity to develop future regulatory compliance frameworks while driving process excellence and innovation across Johnson & Johnson's global clinical development organization!
Key Responsibilities
- Monitor and assess new EU MDR/IVDR regulations, standards, and guidance, evaluating their impact on Clinical Development and the Clinical QMS. Lead regulatory impact assessments, including gap analyses, risk evaluations, and implementation strategies.
- Serve as the primary R&D Quality lead for assigned MDR/IVDR initiatives, partnering with Regulatory, Quality, Legal, and business partners. Drive updates to QMS processes, SOPs, training programs, and governance documentation to ensure ongoing compliance and inspection readiness.
- Support audits, inspections, CAPAs, and continuous improvement initiatives while finding opportunities for automation and operational excellence.
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Education
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management, or a related field required. Advanced degree preferred.
Experience and Skills
Required:
- Minimum 5 years of experience within pharmaceutical, medical device, diagnostics, biotechnology, or clinical research environments. Experience in quality systems, regulatory compliance, clinical development, or related functions.
- Demonstrated expert knowledge of EU MDR, EU IVDR, and/or FDA medical device regulations (including 21 CFR Subchapter H, Part 809, and 510(k)), with practical application in clinical development or clinical research.
- Proven ability to interpret regulations, conduct impact and gap assessments, and translate requirements into effective QMS controls, procedures, and training programs. Experience in leading complex cross-functional projects and managing risk, change, and compliance initiatives within a regulated environment.
- Strong analytical, problem-solving, and partner management skills, with the ability to influence across global matrix organizations. Excellent written and verbal communication skills and proficiency with Microsoft Office applications.
Preferred:
- Experience within medical device, IVD, companion diagnostics, software-enabled medical technologies, or combination product development. Clinical trial, GCP, and ICH guideline experience, including risk-based quality management approaches.
- Experience supporting health authority inspections, audits, CAPA programs, and quality issue management activities. Knowledge of digital tools, data-driven quality solutions, and intelligent automation approaches.
About Johnson & Johnson Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
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Why Join Us?
At Johnson & Johnson, we believe health is everything. Through innovation in healthcare, we are working to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and where solutions are personal.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit Johnson & Johnson Careers.
Equal Opportunity Employer
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Required Skills:
- Critical Thinking
- Data Management and Informatics
- Epidemiology
- Ethical and Participant Safety Considerations
- Inventory Management
- Laboratory Operations
- Laboratory Safety
- Mental Agility
- Preclinical Research
- Problem Solving
- Process Improvements
- Research and Development
- Standard Operating Procedure (SOP)
- Strategic Thinking
- Technical Credibility
- Vendor Management
Preferred Skills:
Anticipated Base Pay Range
The anticipated base pay range for this position is:
Benefits:
In addition to base pay, we offer the following benefits*:
- An annual bonus with set target (% of pay) depending on pay grade/location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
- Vacation days
- Parental leave for a minimum of 12 weeks
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Well-being reimbursement
- Programs for financial, physical, and mental health
- Service anniversary and recognition awards
- Participation in several insurance plans, subject to the terms of their respective plans and eligibility.
For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
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