With over 25 years of experience, they excel in clinical research across the medical device/technology industry including start-ups, focusing on digital health innovation and EU regulatory frameworks
Has a proven track record in managing global clinical programs, from study design to data dissemination, ensuring compliance and successful market authorization
As a Clinical Affairs & Strategy Consultant, they have led teams in developing clinical strategies, regulatory documentation, and quality management for MedTech and SaMD projects
Their strategic expertise includes directing global studies, authoring clinical evaluation reports, and ensuring regulatory compliance, with results published in top medical journals
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Overview
- Availability
- Asap; 0.8 FTE; remote & travel
- Qualification
- Master’s degree in Biology and Biotechnology
- Language Skills
- French (native), English (fluent), German (good)
- Relevant Expertise
- Clinical Strategy, Global Clinical Programs, Clinical Research Excellence, EU Regulatory Frameworks, Clinical Investigation Plan, FDA, MDR, CE-Certification, Audit, Clinical Evaluation Plan, Digital Health, CROs, MedTech, SaMD
Key-Facts
Extract from Previous Activities
Confidential Company
Clinical Affairs & Strategy Consultant
Provide consulting services in clinical strategy, team management and training, clinical project management, regulatory documentation, medical writing, quality management and audit
Designed class I digital therapeutics device’s clinical investigation plan to obtain approval as a digital surrogate endpoint for depression and anxiety (completed protocol development in 4 months, obtained approval in one month)
Led a 2-person clinical team
Developed and structured a data collection program for Class IIa software-and-hardware medical device to meet FDA requirements, supported MDR CE certification
Authored clinical evaluation plans and reports for 4 Class IIa software and hardware devices; supported telemonitoring software certification under MDR without any audit finding and led a 7-person multidisciplinary team through transition to MDR
Medical Technology | Digital Health Company
Chief Clinical Officer
Start-up (20 employees) - Manufacturer of SaMD embedding AI to predict transplant rejection, telemonitoring solution
Participated to the company’s strategy as a member of the executive and steering committees
Managed the clinical team (1 team-member)
Defined and executed the company’s clinical strategy to enable reimbursement and deployment of a class IIa SaMD under MDR in EU, according to budget and timelines
Ensured regulatory and quality compliance through continuous clinical evaluation process, documentation writing per MDR, materiovigilance correspondent and clinical quality process pilot roles
Medical Device Company
Senior Clinical Project Manager
Global mid-size MedTech (~100 employees) - Manufacturer of class III implantable medical devices
Led 4 EU post-market studies (450+ patients, 45+ sites), generating safety and efficacy data to secure CE mark and reimbursement
Managed a global IDE RCT (228 patients, 25 centers) for FDA market approval.
Built the clinical department’s QMS and SOPs, created working and communication tools for the clinical affairs department
Served as GDPR referent for Clinical Affairs, liaising with Legal