Manager, E.U. Medical Device & IVD Regulation

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a Manager, EU Medical Devices & IVD Regulation in Beerse, Belgium, or Beerse, Switzerland or Maidenhead, UK. This role acts as the subject matter expert for EU MDR/IVDR, ensuring integration within the Clinical Quality Management System and guiding regulatory strategy for medical devices and diagnostics.

You will lead regulatory impact assessments, translate regulations into QMS controls, and support audits and continuous improvement across a

Qualifications

• Minimum 5 years of experience in pharmaceutical, medical device, diagnostics, biotechnology or clinical research environments.
• Experience in quality systems, regulatory compliance, clinical development or related functions.
• Expert knowledge of EU MDR, EU IVDR and/or FDA medical device regulations (including 21 CFR Subchapter H, Part 809 and 510(k)).
• Ability to interpret regulations, conduct impact and gap assessments, and translate requirements into QMS controls.
• Experience in leading cross-functional projects and managing risk, change and compliance initiatives.
• Excellent written and verbal communication skills; proficiency with MS Office.

Responsabilités

• Monitor and assess new EU MDR/IVDR regulations 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 programmes 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.

Connaissances

Regulatory compliance

EU MDR/IVDR

Quality systems

Clinical development

Cross-functional leadership

Regulatory inspections

Formation

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management or related field

Advanced degree preferred

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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! Located in Beerse, Belgium; Allschwil, Switzerland; or 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 programmes 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.

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 programmes.
• 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 programmes and quality issue management activities.
• Knowledge of digital tools, data-driven quality solutions and intelligent automation approaches.

Preferred 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

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.

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.

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.

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.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• 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.

The anticipated base pay range for this position is:

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.