Manager, E.U. Medical Device & IVD Regulation

This is a fully remote position, open to applicants in Belgium, +2 more countries.

📋 Description

• Monitor and evaluate new EU MDR/IVDR regulations, standards, and guidance.

• Assess the regulatory impact on Clinical Development and the Clinical Quality Management System (QMS).

• Lead regulatory impact assessments, gap analyses, risk evaluations, and implementation strategies.

• Act as the primary Quality lead for R&D on assigned MDR/IVDR initiatives.

• Collaborate with Regulatory, Quality, Legal, and business stakeholders.

• Facilitate updates to QMS processes, Standard Operating Procedures (SOPs), training programs, and governance documentation.

• Assist in maintaining compliance and readiness for inspections.

• Support audits, inspections, CAPAs, and initiatives for continuous improvement.

• Identify opportunities for automation and enhance operational excellence.

• Shape regulatory compliance strategies across the global clinical development organization.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management, or a related field is required.

• At least 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 understanding 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.

• Capability to interpret regulations, perform impact and gap assessments, and convert requirements into QMS controls, procedures, and training programs.

• Proven experience in leading complex cross-functional projects and managing risk, change, and compliance initiatives within a regulated environment.

• Strong analytical and problem-solving capabilities.

• Partnership management skills with the ability to influence in global matrix organizations.

• Exceptional written and verbal communication skills.

• Proficiency in Microsoft Office applications.

• Preferred: experience in medical devices, 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 with health authority inspections, audits, CAPA programs, and quality issue management.

• Preferred: knowledge of digital tools, data-driven quality solutions, and intelligent automation approaches.

🏝️ Benefits

• Annual bonus with set targets based on pay grade/location, reflecting employee and company performance.

• Vacation days.

• Parental leave for a minimum of 12 weeks.

• Bereavement leave.

• Caregiver leave.

• Volunteer leave.

• Well-being reimbursement.

• Programs focused on financial, physical, and mental health.

• Service anniversary and recognition awards.

• Insurance plans for employees and, in some locations, eligible dependents.