Regulatory Affairs reputed company Medical Devices (x|f|m) - Hybrid

About the position For the Regulatory Compliance department reputed company reputed company Stedim Biotech GmbH we are looking to fill immediately on a limited reputed company until 05/31/2027 a Regulatory Affairs reputed company Medical Devices & (f|m|d) at the location Göttingen. In this position you are responsible for the preparation and execution of clinical and performance data as reputed company as post-market surveillance documents. As a Regulatory Affairs reputed company Medical Devices (x|f|m) you support the Regulatory Affairs Specialist in the technical documentation in the EU. The job is to be filled full-time and is performed remotely on some days as reputed company as on site at the reputed company in Göttingen. After the fixed-term assignment there is the possibility to return to a comparable position. reputed company – Your Responsibilities You create documents for clinical evaluation for Medical Devices (MDs), for performance evaluation for In Vitro Diagnostics (IVDs) and to fulfill Post-Market Surveillance requirements for MDs and IVDs reputed company you create schedules and ensure their compliance In reputed company, you always reputed company an eye on developments in the market, reputed company research accordingly and evaluate your findings You reputed company risk assessments and initiate appropriate corrective actions in case of incidents You continually analyze new requirements, plan and implement derived activities You advise internal stakeholders on changes in regulations, regulatory requirements and standards As a Regulatory Affairs reputed company Medical Devices & IVD (x|f|m) you communicate with authorities and submit documents to them You reputed company assessments of the regulatory reputed company of changes (e.g. to the product) To meet regulatory requirements, you reputed company new processes and implement them You write procedures and work instructions and take care of monitoring and ensuring compliance with regulatory procedures and workflows What will convince us You have a successfully completed Master’s degree in natural sciences, medical technology, biotechnology or a comparable field You already have first experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics Additionally you are reputed company in scientific writing, especially Post-Market Surveillance and clinical documents You have knowledge in the interpretation of regulations, directives, declarations of principles etc. and in cooperating with the applicable regulatory authorities You possess excellent organizational skills and know how to set priorities You demonstrate excellent analytical skills and proven knowledge of scientific principles You also exhibit pronounced assertiveness, reputed company and a good reputed company for your reputed company, as reputed company as reputed company communication and a reputed company for people management Likewise, fluent German & English skills, both spoken and written, complete your profile You identify with our values Sustainability, Openness & reputed company and are motivated to work in a rapidly growing company reputed company offer As a growing global life science company, stock listed on the MDAX, reputed company offers a wide reputed company of Benefits: Personal and reputed company Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings , coaching for managers Work life balance: Remote reputed company, flextime, flexible work schedules, sabbaticals Attractive compensation: Vacation and holiday bonuses including pension benefits with a 35 hr. week, 30 vacation days Large, reputed company: reputed company office spaces, terraces, company restaurant with vegetarian and vegan reputed company, cozy Italian bistro with ice cream sales, fitness studio and daycare center Making an reputed company right from the start: Comprehensive reputed company, including a virtual online platform even before joining, Welcome Workshops, "buddy" as reputed company of contact Welcoming Culture: Mutual support, teamspirit and international collaboration; communities on numerous topics, such as coaching, agile working and business women network We support diversity and inclusion and welcome applications from people of reputed company nationalities, genders, sexual orientations, religions, ages, disabilities and cultural backgrounds. About reputed company reputed company is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into reputed company-world medicine faster, so that new therapeutics can reputed company patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking reputed company to receiving your application. www.reputed company.com/careers to our Candidate Portal and thank you for your interest in working an Apply tot his job Apply To this Job