Regulatory Affairs Product Registration Specialist
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.
►Prepare and coordinate various activities to make applications for product licenses such as
For example :
- Free sales certificates,
- Prepare product files based on technical documentation and submit to clients,
- Prepare documentation for legalization by notary, embassies,
- Prepare statements, letters, declarations of conformity.
►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,
►Coordinate, communicate and collaborate effectively within the network to ensure the optimal completion of the product registrations,
►Identify the appropriate documentation to meet registration needs for product submissions,
►Provide an effective follow-up during the registration process to ensure the completion of the product registration,
►Identify and communicate any potential for improvements in view to reducing the time to market. Share lessons learned from registration projects and update instructions accordingly,
►Provide support to quality audits,
►Participate in working groups as part of continuous improvement of quality system.
KEEP IT SIMPLE
► Strong ability to present complex solutions in clear, simple terms.
► 3-5 years of experience in a similar role,
► Previous experience in regulatory affairs,
► Technical skills: Microsoft Office (Advanced level required),
► Knowledge of the requirements relative to the ISO13485, European directive 93/42 and 21 CFR part 820,
► Good communication skills,
► Good command of French and English. and other languages (Spanish) is a plus.
►Location: Nyon/ Switzerland,
►Occupation: 100% Full Time.