Your Mission
* You will prepare and compile regulatory submission dossiers for new medical device registrations and changes to existing products, in accordance with regulations
* Monitoring new legislations, policies, standards and guidelines that affect the assigned product portfolio will be one of your tasks
* The collaboration with cross-functional teams to collect necessary information is a daily mission for you
* You will conduct post-market surveillance and report adverse events/ field safety corrective actions to the authorities
* In your role you will be supporting currently marketed products, e.g, review engineering changes, product labeling and promotional materials
* We want you to initiate and manage projects for continous improvement and compliance with regulatory requirements
* You will report to the manager and relevant stakeholder on key results, serious incidents, as well as potential opportunities and risks for the company
Your Talents
* Master of Science or Master of Engineering, specializing in medical devices or a related field
* At least 5 years of professional experience in this or a comparable position
* Knowlege of SAP user interfaces like PLM and Easy DM, as well as familiarity with MS Project
* Strong service and customer orientation
* Flexibility to adapt to various situations and personalities
* Ability to work independently
* Fluent in written and spoken English
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