Integrity without compromise

Every day our products and services help to save lives 
around the globe. Therefore, we make quality and 
reliability our number one priority. 

Get to know us and join our team as

Medical Safety Officer (m/f/d)

Job Function:  Patient Health & Regulatory Affairs
Location: 

Tuttlingen, BW, DE, 78532

Work Location (for field-based positions): 
Work Flexibility:  Remote
Job ID:  1690

Your mission

  • 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​

HR Contact

Silva Oberländer

1690