Senior Medical Device Compliance Professional

Vor 2 Tagen


Lausanne, Waadt, Schweiz TN Switzerland Vollzeit

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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