Senior Medical Device Compliance Professional
Vor 2 Tagen
We are looking for a seasoned Senior Regulatory Affairs Specialist to join our team in Aubonne. As a key member of our Regulatory Affairs Department, you will be responsible for providing advanced regulatory support for NPD projects and sustaining operations across designated Business Units. This role requires a deep understanding of EU and global medical device regulations, including ISO 13485, European Medical Device Directive (93/42/EEC), and Medical Device Regulation (2017/745/EU).
Main Activities:- Regulatory Strategy Development: Collaborate in the development and implementation of EU regulatory strategies for new product introductions, product changes, and new indications, ensuring alignment with business goals.
- Regulatory Advice: Provide regulatory advice to cross-functional teams, ensuring product development and changes are in line with current regulatory requirements.
- Regulatory Process Improvement: Participate in process improvement initiatives aimed at enhancing regulatory submission efficiency and effectiveness within the Regulatory Affairs Department.
A minimum of 8+ years of experience in regulatory affairs within the medical device industry is required, with significant experience in EU regulations. A Bachelor's or Master's degree in Engineering, Medical Technology, or a related field is highly preferred.
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Regulatory Affairs Professional
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Regulatory Affairs Specialist with EU Expertise
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EU Regulatory Affairs Lead for NPD Projects
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