Manager, E.U. Medical Device & IVD Regulation

Johnson Johnson; Beerse; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is recruiting a Manager for EU Medical Devices & IVD Regulation. Location options include Beerse, Belgium, with focus on regulatory compliance within Clinical Development and QMS frameworks.

The role requires 5+ years in pharma/medical devices, deep EU MDR/IVDR/FDA knowledge, and proven ability to lead cross-functional initiatives and drive regulatory excellence across a global organization.

Qualifications

• Minimum 5 years of experience in pharma, medical device, diagnostics, biotech or clinical research environments.
• Demonstrated expert knowledge of EU MDR, EU IVDR and/or FDA medical device regulations with practical application in development or clinical research.
• Ability to interpret regulations, perform impact and gap assessments and translate requirements into QMS controls.
• Experience leading cross-functional projects and managing risk, change and compliance in a regulated setting.
• Strong analytical, problem-solving and partner-management skills; excellent written and verbal communication; proficient with MS Office.

Responsabilités

• Monitor and assess new EU MDR/IVDR regulations and their impact on Clinical Development and the Clinical QMS.
• Lead regulatory impact assessments, gap analyses, risk evaluations and implementation strategies.
• Drive updates to QMS processes, SOPs, training programmes and governance documentation to ensure ongoing compliance and inspection readiness.

Connaissances

Regulatory compliance

EU MDR/IVDR knowledge

Cross-functional collaboration

QMS controls

Risk assessment

Inspections/CapA

Communication skills

MS Office

Formation

Life Sciences

Pharmacy

Engineering

Quality Management

Description du poste

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!

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.

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,