General information
Organization
As a market leader, EMS sets new standards in the design, manufacturing and sale of devices used for medical and dental treatments. EMS products benefit from a tradition of flawless Swiss precision and craftsmanship.
Founded more than 30 years ago, EMS offers valuable solutions in the fields of :
„ Dental Prevention – inventors of Guided Biofilm Therapy: evidence based protocol for biofilm management on teeth, soft tissues and implants and the original Airflow®, Perioflow® and PIEZON® technologies.
„ Urology – market leaders in endoscopic lithotripsy, EMS shapes the history and future of stone management with its LithoClast® and LaserClast® product range.
„ Shock Wave Therapy - inventors of RSWT® (Radial ESWT) and developers of the Swiss DolorClast® Method for the effective treatment of muscular-skeletal pathologies and dermatological conditions.
Respect, Excellence and Client orientation are EMS' core values.
Quality is part of EMS' DNA, it is engraved in EMS' Mission.
Happy and healthy patients, successful clinicians and passionate partners, this is EMS' mission. EMS delivers innovative and clinically proven treatment outcomes in the least invasive way. We are committed to fostering knowledge and skills by training and educating healthcare professionals, partners and employees.
Reference number
2023-287
Job details
Job title
RA Specialist M/F
Job description
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.
• 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
• 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
Job criteria
Hiring Date
6/1/2023
Activity Rate
Full time - 100%
Applicant criteria
Minimum level of education required
4- Master
Minimum level of experience required
6 years or more