Ihre Aufgaben
- Assess the regulatory impact of design changes and updates to the existing product portfolio of medical devices.
- Ensure ongoing compliance with regulatory requirements across the US, EU, Japan, and other key markets.
- Provide regulatory expertise within cross-functional teams for new product development.
- Prepare and submit 510(k) premarket notifications to the FDA.
- Develop and execute registration strategies for global markets.
Ihre Qualifikationen
- A university degree in a technical field or equivalent professional experience in regulatory affairs.
- Several years of experience in regulatory affairs within the medical device industry.
- Proven expertise in preparing FDA premarket submissions (510(k)) and evaluating US registration impacts during change management.
- Strong knowledge of relevant standards, such as IEC 60601 and ISO 14971.
- Excellent written and verbal communication skills in English; proficiency in German is a plus.
Ihre Vorteile
-30 days of annual leave
-Up to 60% mobile work possible + flexible work time model with overtime compensation
-Holiday and Christmas bonuses
-Corporate benefits discounts for employees
-Comprehensive company pension scheme and capital-forming benefits
-Company restaurant with live cooking and healthy food (subsidized)
-Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
-Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
-Various subsidized company sports groups and access to the inhouse company gym