EMS is the leading manufacturer of precision medical devices for dental prophylaxis, orthopaedics and urology. With over 900 qualified and specialised employees, we work on further improving our products and services every day – at our corporate headquarters in Nyon and around the world.

With this philosophy, we are continuing a more than 200-year-old tradition of the Swiss Vallée de Joux. This is where EMS was founded – as well as numerous other brands, which are known around the world for their precision down to the smallest detail.

MISSION:

The regulatory affairs specialist provides international regulatory expertise and support throughout the lifecycle of products manufactured and distributed by EMS. As part of the regulatory affairs group within the quality department, the regulatory affairs specialist acts independently and act as a team player in the completion of registrations and the promotion of compliance to applicable regulatory requirements.

TASKS & RESPONSABILITIES

• Contributes to the creation of the registration plan with inputs from Product Manager and manages the execution of the plan considering the priorities and feasibility
• Identify the appropriate documentation to meet registration needs for product submissions. Create the submission file and any other documentation required to complete the submission or support the distributor / consultant by providing required information and documentation
• Coordinate, communicate and collaborate effectively within the network to ensure the optimal completion of the product registrations
• Product life cycle management – provide support for product change requests and new standards by evaluating and documenting impact, by defining action plans (including retesting) and performing registration updates.
• Provide support to internal and external clients by answering requests for regulatory information and advice in a timely manner

PROFILE / BACKGROUND:

• A minimum of 5 years of experience in a similar role
• Engineer’s degree in mechanics / experience in the medical device industry
• Bachelor’s degree / experience in the medical device industry. International regulatory experience with medical device registrations and knowledge of international standards and regulations.
• Good organization skills including planning, follow-up, and communication of task status
• Self-motivated by working independently and able to take ownership of his/her responsibilities, and to work under time pressure, and to organize various projects in a timely manner
• Good oral and written communication skills – ability to work on cross-functional teams.
• Fluent in English and in French is mandatory

By joining our company, you will access to :

• Join a dynamic team in a international environment
• Grow thanks to our EMS university journey
• Participate in amazing winter and summer company parties
• Dynamic environement - Improve patient oral health