14 set - Terni
Bsi Group
OverviewIn 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 / Benefitscompetitive total reward package
flexible working hours
ongoing training and development
remote/homebased work
international environment
ResponsabilitàCollaborate 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 fondamentaliExperienced 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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