Published: 18 April 2024
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Permanent position
This role is based in Vaud, Switzerland and the successful candidate is required to be in the Canton of Vaud.
In this role, you lead the development and improvement of the regulatory affairs capabilities in Europe, Middle East and Africa. You provide strategic guidance regarding the impact of regulatory issues on corporate strategy and operations for the regions. An active member of the Senior Regulatory Leadership Team, you work closely with the European Leadership Team, providing advice and expertise related to regulatory.
For this role, we need successful experience leading a Regulatory Affairs department in Medical Devices products - infusion/insulin pumps or other sophisticated electro-mechanical devices are preferred. You have supported all aspects of regulatory compliance: pre-market, commercial, post-market, and regulatory, including working with regulatory bodies (ideally NMPA, NSAI & BSI).
You have a proven track record of collaborating with senior business partners to develop innovative regulatory strategies resulting in reduced product development costs and/or outstanding review times with regulatory authorities. Extensive knowledge of regulatory standards and laws applicable to the medical device industry is crucial, especially MDD/MDR.
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