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OneTrust

Manager, E.U. Medical Device – IVD Regulation

OneTrust

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

Posted 10/6/2026full-timeRemote • Belgium, United Kingdom, SwitzerlandMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in EU MDR and IVDR regulations, with a strong focus on regulatory compliance, quality management systems, and clinical development. Proven ability to lead cross-functional projects, conduct impact assessments, and drive continuous improvement initiatives within regulated environments.

Highest-signal resume keywords
EU MDR ComplianceRegulatory Impact AssessmentQuality Management Systems (QMS)Clinical Development ExperienceAnalytical Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory ComplianceGap AnalysisRisk EvaluationClinical Quality Management21 CFR Subchapter H510(k) RegulationsClinical ResearchQuality SystemsTraining Programme DevelopmentChange Management
Soft Skills
Analytical SkillsProblem-SolvingPartner ManagementInfluencing SkillsCommunication Skills
Tools & Technologies
Microsoft OfficeDigital ToolsData-Driven Quality SolutionsIntelligent Automation
Industry Keywords
PharmaceuticalMedical DeviceDiagnosticsBiotechnologyClinical ResearchGCPICH GuidelinesCAPA ProgrammesHealth Authority InspectionsSoftware-Enabled Medical Technologies

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • 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

What you’ll need
  • 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

Comp & perks
  • 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