Regulatory Affairs Specialist
vor 4 Wochen
Main Responsibilities
- Support the development of Diabetes Care products, focusing on active and connected devices.
- Develop and implement regulatory strategies to ensure compliance with EU and US regulations.
- Prepare and submit product documentation to regulatory authorities.
- Collaborate with business stakeholders to achieve regulatory goals.
- Communicate with regulatory authorities and coordinate audits.
- Perform general quality management tasks, including document creation and training.
Requirements
- University degree in Engineering, Natural Sciences, or Medical Sciences, or equivalent experience.
- At least 4 years of experience in Regulatory Affairs, with a focus on medical devices.
- Expertise in EU and US regulations for active medical devices.
- Excellent organizational and communication skills.
- Proficient English language skills (C2 or MT level).
Benefits
- Flexible work arrangements, including shift work and part-time options.
- Up-to-date work environment, including modern production facilities and offices.
- Pension fund contributions.
- Mobility support, including charging stations and public transportation.
- Free access to sports facilities and financial support for childcare.
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