Ihre Aufgaben
- Creation, update and management of CERs (Clinical Evaluation Reports) and/or SSCP (Summary of safety and clinical performance)
- Coordination and review of the CERs and/or SSCPs generated by external supplier(s)
- Systematic analysis of clinical evidence related to Olympus products or diagnostic/therapeutic procedures by literature research in relevant data bases (e.g. Pubmed, Embase, Cochrane)
- Close collaboration with various stakeholder in the regional organization (Product Management, Risk Management, R&D, Quality and Regulatory Affairs) to provide input on deliverables, clinical research and literature evidence and support product development process needs
- Planning and initiation of Post-market Clinical Follow-up activities together with Stakeholders
- Forecasting and planning of budget for regional CERs and belonging documents (internal & supplier)/ per fiscal year
- Prepare and support audits as well as other duties as assigned
Ihre Qualifikationen
- Master level degree or PhD in health science related field required
- Minimum of 3 years experience in CER creating required
- Minimum of 3 years business experience in MedTech Industry required
- Strong knowledge of applicable laws and regulations relevant to Clinical Evaluation, e.g. with EU-MDR, EU-MDD, MEDDEV 2.7.1 rev 4, MDCG Guidelines, ISO 14971 Risk Management
- Knowledge of interpretation and analysis of scientific literature
- Highly self-organized and efficient working style
- Demonstrated strong communication skills
- Team-player
- Proficient English both spoken and written
- Good knowledge of MS Office package
#LI-REMOTE#MIDSENIORLEVEL
Ihre Vorteile
-Flexible working hours, remote work possible (up to 60%)
-30 days of holidays per year
-Modern office and an inspiring working environment
-Employee restaurant with live cooking and healthy food (subsidized)
-Public transport ticket (100 % subsidized) or free parking space
-Company sport groups and an inhouse company gym
-Employee Assistance Program to support your health, mental and emotional well-being
-A comprehensive company pension scheme
-Company medical officer and vaccination offers
-Childcare through our ‘Buttje&Deern’ partner
-Bike leasing