Regulatory Affairs Specialist -- Ballaigues, Switzerland
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. As The Dental Solutions CompanyTM, Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better, safer and faster dentistry. Dentsply Sirona’s global headquarters is located in York, Pennsylvania, and the international headquarters is based in Salzburg, Austria. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.
Bringing out the best in people
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.
Working at Dentsply Sirona you are able to:
Develop faster - with our commitment to the best professional development.
Perform better - as part of a high-performance, empowering culture.
Shape an industry - with a market leader that continues to drive innovation.
Make a difference -by helping improve oral health worldwide.
MISSION
As our new Regulatory Compliance Specialist, you will update risk management files and technical documentation according to current regulatory requirements, in close cooperation with R&D, Clinical Research, Post-Market Surveillance, Marketing and Operations.
MAIN RESPONSIBLITIES
- Update technical documentation according to state of the art to ensure that regulatory requirements are met effectively and in a timely manner
- Update technical documentation in response to change controls, PMS data, changes in regulation and standards
- Collaborate transversally with R&D (risk Management, usability engineering, GSPR), clinical research (biological safety and clinical evaluation), PMS, marketing and Operations Ensure consistency between technical files
- Participate in continuous improvement projects
- Consult in Change Control, Labelling review and approval, technical documentation assessment and new product development
- Collaborate with responsible person for product registration in order to facilitate registration process in case of new product developments or product changes
PROFILE
- Bachelor's or master's degree in biomedical science, Regulatory Affairs, engineering (or similar); continuing education in regulatory affairs is a plus
- ~1-3 years of experience in a similar position; solid experience in writing technical documentation for medical devices
- Strong knowledge of international regulations for medical devices (21CFR820, MDR, MDD) and QMS standards (EN ISO 13485)
- Excellent communication skills in English (min. C1) and French (min. B2/C1); German is a plus
- Solid knowledge with Office suite
- Exceptional facilitator with a team-oriented approach
- Strong motivation and drive for results
- Flexibility combined with an open-minded attitude
- Aptitude for precision with an eye for details
- Positive disposition with a solution-oriented mind-set
