Senior Manager - Post-Market Clinical Follow-up - #46378
Straumann Group
We are seeking an experienced and highly motivated professional with strong expertise in Post-Market Clinical Follow-up (PMCF) or Clinical Evaluation within the medical device industry. This position is part of Straumann’s Real-World Evidence (RWE) Team and is based at Straumann Group Headquarters in Basel, Switzerland. The role requires a collaborative and solution-oriented professional who is comfortable working across functions and managing diverse activities in an international environment. Reporting directly to the Team Lead RWE, the successful candidate will play a key role in driving PMCF strategy and execution in alignment with regulatory requirements and broader business objectives.
Key Responsibilities:
- Oversee and continuously enhance PMCF processes and methodologies and contribute to Notified Body audits and technical file review activities
- Evaluate and synthesize clinical data from multiple sources, including scientific literature, registries, surveys, clinical investigations, and scientific meetings
- Establish, maintain, and track PMCF Plans / Reports, including oversight of associated activities, timelines, and deliverables
- Support the integration of PMCF outputs into Clinical Evaluation and Post Market Surveillance documentation
- Establish and, where applicable, implement methods for collecting post-market clinical data outside of clinical investigations (e.g. registry analyses, surveys, real-world evidence initiatives) in collaboration with internal and external stakeholders
Required Qualifications:
- Advanced degree in a relevant field such as Life Sciences, Biomedical Engineering, Dentistry, or related disciplines
- Minimum 5 years of relevant professional experience in PMCF, Clinical Evaluation, Clinical Research, or related fields within the medical device industry
- Strong understanding of EU MDR requirements related to PMCF, Clinical Evaluation, and Post-Market Surveillance
- Strong affinity for clinical and scientific data, including experience translating clinical evidence into regulatory documentation
- Experience with post-market evidence generation approaches such as clinical investigations, registries, and surveys is strongly preferred
- Excellent analytical, organizational, and communication skills with a structured, proactive, and result-oriented working style
- Ability to manage multiple priorities effectively in a dynamic cross-functional and international environment
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type: Full Time
Alternative Locations: Switzerland : Basel
Travel Percentage: 0 - 10%
Requisition ID: 21128
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