To strengthen our current team of medical devices experts, we are looking for a
Senior Regulatory Expert (80-100%)
Two topics are your focus and responsibility:
- Reviewing and compiling technical documentation of medical devices according to MDR
- Compiling 510k submissions in a team
Your knowledge in Technical Documentation is profound. This means that you have special knowledge in most of the topics of annexes II & III of MDR 2017/745.
Besides, you offer client-oriented and creative solutions within the given rules and regulations. You lead projects including time- and budget-management, and you enjoy to share your knowledge in virtual and face-to-face trainings with customers.
The skills and requirements needed for this diversified position:
- MSc degree in a relevant scientific discipline or equivalent (e.g. biocompatibility; toxicology; mechanical engineering; biomechanics or similar).
- Several years of experience in one of the following fields: orthopedics; dental implants or active non-implantable medical devices.
- Being fluent in written and spoken English and German is a must, any other language is an asset.
- As a plus you have advanced knowledge in design validation.
A structured and systematic, scientific work approach is required. To work independently and also in teams having the necessary social and interpersonal skills, rounds off the profile.
We are a multi-disciplinary, multi-cultural and self-motivated team of experts. Strong ethical values drive our professional and personal relationships. Axxos offers interesting projects from a wide variety of medical disciplines keeping you up-to-date with ample opportunities to learn and share. Last but not least, flexible working hours, above average salary and decent social security conditions are also included in this attractive offer.
Working place is according to needs: at office in Aarau, at customer’s facility or in home office.
For further information and/or to submit your application, please contact the head of the team Mr. Peter Wehrli, directly. He is happy to assist (p.wehrlinoSpam@axxos.noSpamch).
You can find the job offer as pdf here.
Notice to recruiters:
This employment ad does not constitute an invitation to recruiters to submit any resumes and/or candidates to Axxos. Any details on candidates sent to Axxos by recruiters do not establish any contractual or other kind of relationship between the sender and Axxos nor any obligation of Axxos to pay any fees or similar compensation whatsoever, even in case it should ultimately hire a candidate whose details it has received from such a sender. Recruiters are requested to refrain from contacting Axxos employees directly.