16 set - Prato
Bsi Group
Overview
In this role you join our Medical Device Notified Body as an Internal Clinician, bringing clinical expertise to support conformity assessments. You will review technical documentation and clinical evidence to judge sufficiency and quality of data. You will collaborate with cross-functional teams to ensure clinical data meets regulatory expectations and contribute to best-practice guides and training. This position offers impact across product safety, performance and post-market surveillance in a global, mission-driven organization.
Retribuzione / Benefits
- competitive total reward package
- flexible working hours
- ongoing training and development
- remote/homebased work
- international environment
Responsabilità
- Collaborate with clinical teams to appraise manufacturers' clinical evidence for device conformity
- Assess equivalence rationales, risk assessments, and clinical claims relevant to use, indications, and warnings
- Evaluate PMCF and post-market surveillance to confirm ongoing safety and vantaggi
- Coordinate workload by assigning cases to appropriate medical experts
- Mentor staff and external clinicians to ensure rigorous clinical data reviews
- Develop internal best-practice guides for clinical evaluation and data requirements
- Provide clinical support to commercial/marketing teams as needed
- Appoint external experts for novel technologies
Requisiti fondamentali
- Experienced clinician with broad device exposure and competency across indications
- Proven ability to analyse clinical data and understand clinical investigations
- Knowledge of regulatory clinical evaluation processes and conformity assessment
- Collaborative mindset
- Mentorship and training ability
- Strong communication and cross-functional collaboration
- Clinical data analysis
- Understanding of clinical investigations
- Regulatory conformity assessment knowledge
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