Regulatory Affairs Group Leader Medical
FULL TIME PERMANENT
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.
At EMS we strive for perfection and are committed to improving the quality of life for clinicians and their patients by providing innovative solutions that deliver proven treatment outcomes.
Quality is part of EMS’ DNA, it is engraved in EMS’ Mission.
EMS believes that they can accomplish this Mission only by providing effective, safe, and reliable solutions exceeding consumers'expectations.
As Regulatory Affairs Group Leader within our Quality department, you will lead the Medical Regulatory Affairs Group in view to the successful registration of medical products in worldwide markets and supporting medical product sales plans. In this role, you will be in charge of the following responsibilities:
►Product registration submissions:
- Create a network of support including internal colleagues, distributors and consultants, to provide technical expertise during preparation of submission and in case of requests from authorities during the registration process;
- Identify the appropriate documentation and create the submission file and any other documentation required to complete the submission.
- Acquire up-to-date information relating to the international regulatory and technical requirements for product registrations;
- Provide support to internal and external clients by answering requests for regulatory information and advice in a timely manner;
- Perform feasibility evaluations, provide regulatory strategy evaluations for development projects in view to reducing time to market;
- Regulatory review of technical documentation including test reports, brochures;
- Product life cycle management – provide support for product change requests and new standards by evaluating and documenting impact, by defining action plans and registration updates.
KEEP IT SIMPLE
► Strong ability to present complex solutions in clear, simple terms.
► Bachelor's degree minimum;
► At Least 5 years of experience in the medical device industry and experience in team management;
► Knowledge of European and international medical device directives, regulations and standards;
► Good communication skills and ability to work on cross-functional teams;
► Proactive, leadership and positive-minded;
► Fluent French and English.
► Location:Nyon / Switzerland
► Occupation: Full-time.