Regulatory Affairs Professional Medical Devices (x|f|m) - Hybrid
About the position For the Regulatory Compliance department within Sartorius Stedim Biotech GmbH we are looking to fill immediately on a limited basis until 05/31/2027 a Regulatory Affairs Professional 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 well as post-market surveillance documents. As a Regulatory Affairs Professional 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 well as on site at the campus in Göttingen. After the fixed-term assignment there is the possibility to return to a comparable position. Grow with us – 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 Further you create schedules and ensure their compliance In addition, you always keep an eye on developments in the market, perform research accordingly and evaluate your findings You perform 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 Professional Medical Devices & IVD (x|f|m) you communicate with authorities and submit documents to them You perform assessments of the regulatory impact of changes (e.g. to the product) To meet regulatory requirements, you develop 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 experienced 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, resilience and a good sense for your counterpart, as well as clear communication and a knack for people management Likewise, fluent German & English skills, both spoken and written, complete your profile You identify with our values Sustainability, Openness & Joy and are motivated to work in a rapidly growing company What we offer As a growing global life science company, stock listed on the MDAX, Sartorius offers a wide range of Benefits: Personal and Professional Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings , coaching for managers Work life balance: Remote options, flextime, flexible work schedules, sabbaticals Attractive compensation: Vacation and holiday bonuses including pension benefits with a 35 hr. week, 30 vacation days Large, modern campus: Open office spaces, terraces, company restaurant with vegetarian and vegan options, cozy Italian bistro with ice cream sales, fitness studio and daycare center Making an impact right from the start: Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as point 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 all nationalities, genders, sexual orientations, religions, ages, disabilities and cultural backgrounds. About Sartorius Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach 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 forward to receiving your application. www.sartorius.com/careers to our Candidate Portal and thank you for your interest in working and growing with us. We look forward to receiving your application. You can check the status anytime in this portal. Here you will find the best application tips from our HR team. Information on the application process can also be found in this video and under FAQ & Contact. In this brochure you will learn more about us as an employer and your career with us. For further insights, please visit the Sartorius Blog and our career website. Set up your personal Job Alert now and never miss an opportunity to apply for a job that suits you. Please note that you will receive an initial confirmation message. You'll need to confirm your selection to start receiving job alerts tailored to your preferences. 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 • Further you create schedules and ensure their compliance • In addition, you always keep an eye on developments in the market, perform research accordingly and evaluate your findings • You perform 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 Professional Medical Devices & IVD (x|f|m) you communicate with authorities and submit documents to them • You perform assessments of the regulatory impact of changes (e.g. to the product) • To meet regulatory requirements, you develop new processes and implement them • You write procedures and work instructions and take care of monitoring and ensuring compliance with regulatory procedures and workflows Requirements • 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 experienced 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, resilience and a good sense for your counterpart, as well as clear communication and a knack for people management • Likewise, fluent German & English skills, both spoken and written, complete your profile • You identify with our values Sustainability, Openness & Joy and are motivated to work in a rapidly growing company Benefits • Personal and Professional Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings , coaching for managers • Work life balance: Remote options, flextime, flexible work schedules, sabbaticals • Attractive compensation: Vacation and holiday bonuses including pension benefits with a 35 hr. week, 30 vacation days • Large, modern campus: Open office spaces, terraces, company restaurant with vegetarian and vegan options, cozy Italian bistro with ice cream sales, fitness studio and daycare center • Making an impact right from the start: Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as point 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 all nationalities, genders, sexual orientations, religions, ages, disabilities and cultural backgrounds Apply tot his job