Evelyne Buehler
Over a decade of experience at a medical device manufacturer with class I to III devices.
Main focus on Post-Market Clinical Follow-up but also close interactions with Clinical Research, Clinical Evaluation and Post-Market Surveillance.
Professional Experience
Post-Market Clinical Follow-up positions at Institut Straumann AG - over 8 years
12/2023 – 07/2026
Senior PMCF Manager
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Contributed to the strategic and operational management of PMCF activities across the product portfolio
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Established and maintained PMCF plans and reports
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Provided input to Clinical Evaluation and Post-Market Surveillance documentation
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Synthesized and reported clinical data from scientific literature, registries, surveys, clinical investigations and scientific conferences
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Planed, coordinated and oversaw PMCF deliverables and timelines
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Continuously improved PMCF processes and methodologies in collaboration with internal and external stakeholders
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Supported Notified Body audits and technical file reviews
08/2022 – 11/2023
PMCF Team Leader
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Led the newly created PMCF team
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Oversaw, prioritized and allocated PMCF assignments
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Supervised the PMCF strategy over the entire Straumann product portfolio and led the PMCF process
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Provided functional leadership and supervision to a PMCF Manager
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Acted as the primary contact for PMCF-related requests from Notified Bodies during audits and technical file reviews
06/2018 – 07/2022
Clinical Program Manager
- Established and continuously developed the PMCF process to ensure compliance with the medical device regulation (MDR) in alignment with Clinical Evaluation, Risk Management and Post-Market Surveillance
- Developed and advanced the PMCF strategy for the Straumann product portfolio including identifying innovative approaches to generate post-market clinical evidence
- Oversaw the planning and execution of PMCF tasks in collaborations with internal stakeholders
- Coordinated the execution of PMCF tasks with cross-functional stakeholders
- Established and maintained PMCF plans and reports
- Identified and implemented appropriate PMCF activities to generate required clinical evidence
- Followed-up on PMCF activities and participated in the cross-functional evaluation of identified signals
- Contributed to Clinical Evaluation, Post-Market Surveillance and Clinical Research documentation
- Acted as the primary contact for PMCF-related requests from Notified Bodies during audits and technical file reviews
Clinical Study Management positions at Institut Straumann AG - over 4 years
04/2014 - 05/2018
Clinical Trial Leader
Clinical Research Associate
- Managed sponsor-initiated post-market clinical investigations for medical devices in accordance with ISO 14155
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Managed investigator-initiated studies globally
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Established and maintained relationships with investigators and study teams
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Coordinated and managed external service providers including CROs, statisticians and medical writers
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Collaborated with and aligned internal stakeholders including Regulatory Affairs, Product Management and Legal
Core Expertise
PMCF
Designing and executing PMCF plans and reports in line with EU MDR.
Clinical Evaluation
Developing and maintaining clinical evaluation reports (CERs) to support global regulatory compliance.
Post-Market Surveillance
Executing proactive post-market surveillance of medical devices to improve and ensure patient safety standards.
Clinical Research
Strategic planning and management of clinical studies from initial concept to publication.
Project Leads
Efficiently coordinating high-complexity projects within Clinical Affairs and Regulatory Affairs.
Education
ETH Zurich
Bachelor & Master in Human Movement Sciences
Specializing in Biomechanics
Training & Certifications
MDR / PMCF / Clinical Eval
- EU Medical Device Regulation (MDR 2017/745), PMCF Strategy & MDCG Guidance, Clinical Evaluation under MEDDEV 2.7/1 Rev. 4, Quality Management (ISO 13485) and Risk Management (ISO 14971) standards.
Clinical Research
- Good Clinical Practice (GCP) & ISO 14155, clinical study design and methodology, statistical data analysis in clinical trials, monitoring and site management.
Other
- Courses in Leadership and Team Management, Project Management in agile environments, and Strategic Stakeholder Management.