You serve as Medical Safety representative for the review and/or approval of CER, PMCF, periodic safety reports (incl. PMS, PSUR, SSCP) and risk management file documents
You provide medical expertise in assessing patient/user safety risks through the development, support, review, and approval of safety evaluations, case risk assessments, health hazard evaluations, and safety signals as well as to cross-functional teams, safety committees, taskforces, work streams, and business partners, representing Medical & Scientific Affairs positions, processes, and guidance
You ensure appropriate metrics for assessing patient safety processes, represent product safety views, and lead in a matrix environment through scientific expertise and organizational influence
The support of the Complaints & Vigilance department with post-market complaint and regulatory reporting requirements is also one of you tasks, specifically, as it pertains to the assessment of harm for a particular event
You continuously contribute to and review the product's harms and hazards list, ensuring consistency in severity of harm determinations throughout the risk management process, pre- and post-market
To contribute to departmental and cross-functional improvement initiatives belongs to your task area
You promote safety awareness and a patient-centric mindset throughout the global Karl Storz organization
Your talents
Medical degree or comparable education
At least 5 years of clinical experience and 3 years of medical device industry and/or pharmaceutical experience
Experience in risk evaluation and mitigation
High level of medical competence, with an ability to balance this with industry standards to achieve business goals
Strong scientific analytical reasoning skills
Ability to work on multiple complex projects in parallel
English language skills required, German language skills would be an asset
Willingness and ability to travel: up to 20%
Your Benefits Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required 30 vacation days and various special payments Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more Corporate benefits and bicycle leasing Subsidy for private pension plan and company health management Various childcare options – at the headquarters in Tuttlingen Health, sports, cultural and leisure activities – offers vary depending on location