Manager, E.U. Medical Device – IVD Regulation

Job not on LinkedIn

🔥 37 minutes 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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OneTrust

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

📋 Compliance

☁️ SaaS

🏢 Enterprise

💰 $150M Series D - OneTrust on 2023-07

Compliance • SaaS • Enterprise

OneTrust is a company that provides a privacy, security, and governance software platform. Its cloud-based (SaaS) offering helps organizations manage data privacy, consent, regulatory compliance, vendor/third-party risk, and related governance and security processes, primarily for enterprise customers.

📋 Description

• Monitor and assess new EU MDR/IVDR regulations, standards and guidance • Evaluate regulatory impacts on Clinical Development and the Clinical Quality Management System • Lead regulatory impact assessments, including 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 partners • 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 (% of pay) depending on pay grade/location, with actual amount 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