Senior Regulatory Affairs Specialist – MedTech (m/f/d)

We are looking for highly motivated and committed Senior Regulator Affairs Specialists who want to immerse themselves in a wide range of industries and international teams and to use their competencies in customer projects. Become part of an excellent and highly motivated team that understands and strives to take as much knowledge as possible. Even if you are learning to see more opportunities than problems in the world and are willing to join our mission to make projects successful, then you are right with us!

Your tasks You are responsible for regulatory evaluation of product changes and technology transfers in close cooperation with R&E, marketing and production The identification of regulatory requirements and potential market access barriers (e.g. federal and federal requirements, refund regulations, shopping communities) are in your hand. You anticipate the development and updating of regulatory strategies taking into account new legal requirements You evaluate new products with regard to regulatory classification and competence You are responsible for defining national and international requirements for admissions, submission channels and compliance activities The creation and submission of electronic and paper-based admission documents according to applicable regulatory requirements is your responsibility You take over regulatory advice during product development, market launch and maintenance phase Communication and coordination with regulatory authorities during the entire authorisation and testing process is guided by you You evaluate preclinical, clinical and production changes with regard to necessary submissions The identification, monitoring and submission of reportable and notifications in clinical trials is in your hands You're planning existing product registrations and implementing necessary changes

MUST HAVE You have a Bachelor's degree in Engineering, Natural Sciences or a comparable subject area You bring at least 3 years of experience in a highly regulated environment (e.g. FDA-regulated industry) with You have at least 2 years of experience in Regulatory Affairs Your knowledge of regulatory processes is very good You work structured, independent and conscientious The targeted and professional coordination and communication with different departments and hierarchical levels can be mastered You can understand complex relationships You have the ability to solve the problem Within your activity you are always one step ahead and act proactively Your excellent communication skills ensure that you can win others for you and convince them of your ideas Your empathy and conflict resolution skills ensure that you can quickly fit into new teams and be effective You have fun working on interdisciplinary and international teams The willingness to travel (20%) and the extra mile to advance projects NICE TO HAVE RAC certification or further completion (e.g. Master Regulatory Affairs) Experience with US Class II and/or Class III medical devices Experience in the creation of approval dossiers (e.g. 510(k), PMA) routine in direct dealing with regulatory authorities

Absolutely serious claim to be the best in project management, to implement project management in perfection and to make projects successful Sensual work that makes a difference An excellent onboarding The opportunity to develop yourself personally and professionally A supportive, capable and varied working environment A passionate, open and inspiring team that sees more opportunities than problems Access to fascinating projects in relevant industries An inspiring and beneficial working environment with space for any kind of work (focus, team, hybrid) Regular & special team events Weekly 1:1s with your leadership for open exchange and continuous feedback Free drinks & snacks at the office