Manager, Regulatory Affairs Process Support, Data Integrity and Compliance EMEA

Johnson & Johnson
High Wycombe
2 days ago
Create job alert

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:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

Johnson & Johnson Innovative Medicine Regional Regulatory Affairs is recruiting for a Manager, Regulatory Affairs Process Support, Data Integrity and Compliance with focus on EU.

About 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.

Learn more at jnj.com/innovative-medicine

This role supports the Regulatory Affairs (RA) EMEA Strategy Organisation Therapeutic Area (TA) teams with leadership for RA processes, data integrity and compliance.

The role partners closely with all RA teams in EMEA, as well as with cross-regional and global stakeholders in the GRA organisation, to deliver sustainable solutions and support stakeholder needs. This role will also connect with relevant cross-functional partners in the region, e.g. Commercial Quality and Medical Safety for cross-functional alignment on process, data and compliance topics.

This role is a member of the Regulatory Affairs Process Support, Data Integrity and Compliance team within Cross-Regional Operations and Strategic Support (C-ROSS) and a key contributor to the team's success.

Key Responsibilities

Regulatory Affairs Process Support

  • Provide strategic support and tactical advice to EMEA RA Therapeutic Area (TA) teams in Europe on optimal and compliant application of RA procedures and processes, including interpretation and implementation of regulatory requirements, systems and processes

  • Coordinate input into global/regional processes and procedures impacting EMEA RA TA teams, partnering with assigned Subject Matter Experts (SMEs) as applicable

  • Ensure, coordinate, develop and/or deliver training and communication on RA processes to EMEA RA TA teams, in collaboration with assigned business process owners and SMEs

  • Identify and drive process alignment and improvement opportunities across EMEA RA TA teams.

  • Act as the coordinator/owner of assigned EMEA RA TA processes.

Regulatory Affairs Data Integrity

  • Ensure robust tracking and maintenance of EU RA data in J&J’s and European Medicines Agency’s (EMA) systems and tools

  • Provide guidance, trainings and communication on EU RA data tracking requirements in J&J’s and EMA’s systems and tools

  • Coordinate/provide input from an EU perspective on global RA data tracking systems, tools, requirements, projects and processes

  • Provide support and advice to EMEA RA TA teams on efficient and compliant use of RA data systems and tools.

Regulatory Affairs Compliance

  • Ensure the appropriate level of compliance in the RA EMEA Strategy Organisation

  • Coordinate contributions from EMEA RA TA teams to audits and inspections, as needed

  • Coordinate assessment and implementation of new/revised EU regulatory requirements with RA EMEA TA impact

  • Advise EMEA RA TA teams on identification and management of non-conformances, CAPAs, quality or compliance issues.

Minimum Qualification

  • At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities, including proven expertise in EU Centralised Procedure, GxP and compliance activities

  • Excellent understanding of EU/EEA pharmaceutical Marketing Authorisation and Clinical Trials regulatory procedures and digital interactions with Health Authorities in EU/EEA

  • Understanding of regulatory data planning and tracking processes and systems, as well as EU data requirements (e.g. SPOR, XEVMPD)

  • Knowledge of RA compliance requirements and advanced process thinking

  • Good technical skills and computer proficiency

  • Proven ability to monitor multiple actions and timelines and follow up until timely completion

  • Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level

  • Excellent cross-cultural interpersonal and influencing skills

  • Ability to communicate effectively in English, verbally and in writing

  • Flexibility and proactivity

  • Team-player

Other requirements

  • This position is based in Europe (Netherlands, Poland, Portugal, Spain, UK)

  • Reachable during Europe office hours and outside office hours in case of emergencies

  • Flexibility for limited travel within Europe (~5%)

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

Spain, Portugal, Poland, The Netherlands - Requisition Number: R-063275

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Required Skills:

Preferred Skills:

Fact-Based Decision Making, Industry Analysis, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility


#J-18808-Ljbffr

Related Jobs

View all jobs

Regulatory Affairs Process Lead, Data Integrity & Compliance

Regulatory Affairs Data Specialist

Regulatory Affairs Data Specialist

Regulatory Affairs Systems and Data Manager

Regulatory Affairs Systems and Data Manager

European Technical Services Manager

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

How Many Medical Technology Tools Do You Need to Know to Get a Medical Technology Job?

If you’re pursuing a career in medical technology, it can feel like the toolkit is endlessly long: imaging systems, data analysis software, regulatory platforms, testing frameworks, prototyping tools, CAD, quality management systems, signal processing libraries and more. Scroll job boards or LinkedIn, and it’s easy to think you need to know every tool under the sun just to secure an interview. Here’s the honest truth most hiring managers won’t explicitly tell you: 👉 They don’t hire you because you know every tool — they hire you because you understand the underlying principles and can apply the right tool in the right context to solve real problems. Tools matter — absolutely — but they are secondary to problem-solving ability, clinical awareness, engineering rigour and the ability to deliver safe, reliable solutions. So how many medical technology tools do you actually need to know to get a job? For most job seekers, the answer is far fewer than you think. This article explains what employers really want, which tools are core, which are role-specific, and how to focus your learning so you look confident, competent and end-game ready.

What Hiring Managers Look for First in Medical Technology Job Applications (UK Guide)

Medical technology (MedTech) is one of the most dynamic and high-impact sectors in the UK — spanning medical devices, diagnostics, digital health, AI-assisted systems, wearables, imaging, robotics and clinical software. At the same time, hiring managers are exceptionally selective because MedTech roles demand technical excellence, regulated safety awareness, clinical context and cross-disciplinary collaboration. Whether you’re applying for roles in R&D, engineering, quality & regulatory, clinical validation, product management or software development for medical systems, hiring managers don’t read every word of your CV. They scan it quickly — often deciding within the first 10–20 seconds whether to continue reading. This guide breaks down exactly what hiring managers look for first in medical technology applications — and how you can make your CV, portfolio and cover letter stand out in the UK market.

The Skills Gap in Medical Technology Jobs: What Universities Aren’t Teaching

Medical technology — also known as medtech — is transforming healthcare. Innovations in diagnostics, imaging, wearable sensors, robotics, telehealth, digital therapeutics and advanced prosthetics are improving outcomes and saving lives. As the UK’s National Health Service (NHS) modernises and a thriving life sciences sector expands, demand for medtech professionals is growing rapidly. Yet employers across the UK consistently report a frustrating problem: many graduates are not ready for real medtech jobs. Despite strong academic credentials, candidates often lack the practical, interdisciplinary skills needed to contribute effectively from day one. This is not a question of effort or intelligence. It is a widening skills gap between university education and the applied demands of medical technology roles. This article explores that gap in depth — what universities are teaching well, where programmes fall short, why the gap persists, what employers actually want, and how jobseekers can bridge the divide to build thriving careers in medical technology.