CAScination AG is an award-winning medical technology company dedicated to development, manufacturing and commercialization of innovations in computer-assisted and image-guided surgery. Our trailblazing navigation systems and surgical robots are designed to improve outcomes for patients undergoing surgical or interventional procedures and offer new perspectives to patients worldwide.
To strengthen our Quality and Regulatory team in Berne (Switzerland) we are looking for a
Quality & Regulatory Affairs Manager
In this position, you will represent the Quality & Regulatory department in development projects and will oversee product compliance on the European, Asian and U.S. markets. You have the opportunity to cover a range of exciting development projects and to support CAScination in regulatory tasks worldwide.
▪ Prepare, submit and maintain technical documentation files for different devices in collaboration with the R&D and clinical research teams
▪ Manage registrations in different markets (Europe, USA, Asia)
▪ Manage post-market activities
▪ Represent quality management and regulatory affairs in various development projects
▪ Support requirement development and risk management processes
▪ Support V&V testing, usability testing and testing relating to standards compliance
▪ Liaise with Notified Bodies
▪ Participate in quality projects
▪ Minimum Bachelor's degree in science, engineering, healthcare or related field
▪ Work experience in a small- to mid-size medical device company
▪ Experience with U.S and European market regulatory requirements in the medical device sector
▪ Experience with ISO 13485 Experience with other ISO/IEC standards is a plus (10993, 14971, 60601, 62304, etc.)
▪ Understanding of clinical evaluations and clinical trials is a plus
▪ 510(k) or PMA submissions experience is a plus
▪ Ability to work independently and as a team player
▪ Excellent communication and documentation skills
▪ English language is a must, German is a plus
As one of the fastest growing companies of Switzerland, CAScination operates in an international and dynamic environment. To meet the high requirements of customers, investors, and authorities, our young and diverse team is constantly searching for the best and most innovative solutions. This requires a high involvement and sense of responsibility of each team member.
Does this role pique your interest? Then please send us your complete application documents* (CV, motivation letter, working references, diploma, etc.).
Stefan Aebischer, Head of Finance and Administration
Phone: +41 31 552 04 30
* Applications from recruitment agencies will not be considered.