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Posted: 10/12/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CE type and CE design dossier evaluations under European Regulations, with a strong focus on ensuring device safety and effectiveness. Proficient in producing comprehensive review reports and coordinating with multidisciplinary teams to meet regulatory standards.
Highest-signal resume keywords
CE Design Dossier ReviewRegulatory ComplianceTechnical Documentation EvaluationHealthcare Product ExperienceExcellent Communication Skills
About the role
Key responsibilities & impact- Conduct CE type and CE design dossier/product review evaluations under applicable European Regulations for different device classes and medical devices/IVDs
- Review design dossiers and technical documentation independently or as part of an evaluation team
- Verify whether devices meet relevant standards and regulatory requirements
- Produce comprehensive review reports supporting or rejecting manufacturers' CE marking applications
- Assess whether devices are demonstrated to be safe and effective, meet intended use, and can be recommended for CE certification to the notified body
- Coordinate with product reviewers/evaluators, clinical experts, performance evaluators, process experts, technical experts, and certification project managers
- Meet review timelines and ensure quality and consistency through consolidation of reviews/assessments
- Participate in standardization, technical, regulatory workshops, and speaking events
- Monitor regulatory developments and communicate new requirements within the team
- Lead or facilitate training sessions and technical days
- Perform other duties as required, requested, or delegated
Requirements
What you’ll need- Successful completion of a university or technical college degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences
- 4 years of professional experience in healthcare products or related activities, such as manufacturing, auditing or research
- 2 of those years in the design, manufacture, testing, or use of the device or technology to be assessed, or related scientific aspects
- English language proficient
- Ability to meet deadlines
- Confidentiality and impartiality
- Reliability and accountability with good organizational skills
- Ability to manage competing priorities
- Ability to work in a team
- Critical reasoning
- Excellent verbal and written communication/presentation ability
- Ability to draw up demonstrative records and reports
- Ability to travel for business purposes
Benefits
Comp & perks- Full-time exempt position
- Business travel may be required
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
CE Marking ApplicationsDevice Safety AssessmentTechnical Report WritingRegulatory Standards KnowledgeDesign and Manufacturing Processes
Soft Skills
Critical ReasoningOrganizational SkillsTeam CollaborationReliabilityImpartiality
Industry Keywords
Medical DevicesIVDsEuropean RegulationsPerformance EvaluationStandardization Workshops