Sankt Gallen Metropolitan Area
- Coordinating clinical trials, PMCF surveys, PMS activities. - Development of clinical data collection and communication strategies. - Reworking and optimizing of SOPs and templates. - Improvement of cross-functional collaboration & communication. - Project management & project lead for cross-functional technical file MDD-MDR transitions and new product development projects. - Internal auditor (MDR, MDSAP, ISO 13485). - Leading a team of seasoned experts specialized in clinical evaluation (MDR, MDCG, MEDDEV 2.7/1 rev. 4) biological evaluation (ISO 10993 series, MDR) chemical regulation (REACH, CLP, MDR)
- Planning and creating of clinical evaluations, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) documents according to MDR, MDCG, and MEDDEV guidelines. - Conducting literature and regulatory database searches including planning, documenting, grading, and appraising of literature. - Identifying clinical data towards sufficiency, communicating gaps, and uncertainties with stakeholders. - Reworking and optimizing of SOPs and templates. - Workflow automation. - Project management & project lead for cross-functional technical file MDD-MDR transitions. - Internal auditor (MDR, MDSAP, ISO 13485).