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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical direction and medical safety systems, with a strong focus on certification decisions, medical device classification, and compliance with CE and ISO standards. Proven ability to lead clinical operations teams and engage with regulatory bodies while ensuring product safety and clinical excellence.
Highest-signal resume keywords
MDClinical DirectionMedical Device ClassificationQuality or Regulatory RoleFluent in French and English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical StandardsRisk PostureIncident HandlingCertification DecisionsMedical Safety SystemClinical JudgementProtocol DevelopmentEvidence ThinkingAI UtilizationTravel Willingness
Soft Skills
LeadershipTeam ManagementCommunication
Industry Keywords
HealthtechDiagnosticsPharmaceutical Medical AffairsCRORegulatory Compliance
About the role
Key responsibilities & impact- Own Lucis's clinical direction and medical safety system
- Decide what the company tests, why it tests it, and the applicable clinical standards
- Set the risk posture and governance model, including approvals, incident handling, and permissible claims
- Own the certification decision and path, including medical device classification, CE, ISO, or out-of-scope determinations
- Hire and lead the clinical operations and safety team
- Represent Lucis clinically with labs, insurers, institutional partners, and regulators alongside the CMO
- Set product safety standards for each release
- Participate in clinical judgement, protocol and evidence thinking, writing samples or case work, and an at-home case study
Requirements
What you’ll need- MD required
- Roughly 5 to 10 years of hospital practice
- Experience leading people and systems in healthtech, diagnostics, pharmaceutical medical affairs, or a CRO
- Experience holding a quality or regulatory role
- Ability to make and own certification decisions, including medical device classification, CE, and ISO considerations
- Ability to set standards and orchestrate doctors to execute the clinical vision
- Fluent in French and English, spoken and written
- Uses AI in daily work and can explain failure modes and responses
- Willingness to travel regularly to Paris for Europe-based candidates
- Additional language is a plus
Benefits
Comp & perks- Relocation support possible
- Flexible arrangement for the right senior profile
- Additional language a plus