Manager, E.U. Medical Device & IVD Regulation

Job not on LinkedIn

🔥 12 hours ago

🌐 Belgium, United Kingdom, +1 more countries – Remote

🇧🇪 Belgium – Remote 🇬🇧 United Kingdom – Remote 🇨🇭 Switzerland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1886

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• Monitor and assess new EU MDR/IVDR regulations, standards and guidance • Evaluate regulatory impact on Clinical Development and the Clinical QMS • Lead regulatory impact assessments, gap analyses, risk evaluations and implementation strategies • Serve as primary R&D Quality lead for assigned MDR/IVDR initiatives • Partner with Regulatory, Quality, Legal and business stakeholders • Drive updates to QMS processes, SOPs, training programmes and governance documentation • Support ongoing compliance and inspection readiness • Support audits, inspections, CAPAs and continuous improvement initiatives • Identify opportunities for automation and operational excellence • Influence regulatory compliance strategies across the global clinical development organization

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management or a related field 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 • Expert knowledge of EU MDR, EU IVDR and/or FDA medical device regulations, including 21 CFR Subchapter H, Part 809 and 510(k) • Practical application of regulations in clinical development or clinical research • Ability to interpret regulations, conduct impact and gap assessments, and translate requirements into QMS controls, procedures and training programmes • Experience leading complex cross-functional projects and managing risk, change and compliance initiatives within a regulated environment • Strong analytical and problem-solving skills • Partner management skills and ability to influence across global matrix organizations • Excellent written and verbal communication skills • Proficiency with Microsoft Office applications • Preferred: experience within medical device, IVD, companion diagnostics, software-enabled medical technologies or combination product development • Preferred: clinical trial, GCP and ICH guideline experience, including risk-based quality management approaches • Preferred: experience supporting health authority inspections, audits, CAPA programmes and quality issue management • Preferred: knowledge of digital tools, data-driven quality solutions and intelligent automation approaches

🏖️ Benefits

• Annual bonus with set target depending on pay grade/location, based on employee and company performance • 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 • Insurance plans for employees and, in some locations, eligible dependents