Regulatory Affairs Professional Medical Devices (x|f|m) - Hybrid job opportunity at Sartorius AG.

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DatePosted 30+ Days Ago bot
Sartorius AG Regulatory Affairs Professional Medical Devices (x|f|m) - Hybrid
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Pattern: full-time
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degreeAssociate
loacation Goettingen, Germany
loacation Goettingen....Germany

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 (x|f|m) at the location Goettingen. 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. 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 ( x|f|m ) at the location Goettingen. 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 In this position you take ownership of compiling, maintaining, and enhancing the EU technical d ocumentation for our medical devices, ensuring full regulatory compliance In your daily work, you collaborate closely with internal stakeholders and guide them through the EU registration process, while keeping them informed about new standards, guidelines, and regulatory requirements, e. g. CE-Mark Acting as a key liaison to our notified b ody , you manage correspondence and actively participate in audits related to EU medical device registrations Your role also includes preparing, updating, and improving internal Quality Management System documents and processes so they align with EU regulatory expectations When product changes arise, you evaluate their regulatory impact for the EU and international regions and work hand-in-hand with global Regulatory Affairs colleagues You contribute your expertise to Product Management and Customer Support by addressing regulatory questions regarding our medical devices To stay ahead, you monitor your own training needs and request additional development whenever necessary As backup for the Regulatory Affairs Manager Labelling, you support various labelling tasks and ensure that label content meets all relevant medical device requirements On request, you assess label changes, conduct regulatory gap analyses, and manage associated Change Control (CCR) activities in SAP During audits and inspections, you serve as the subject matter expert for medical device labelling topics 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

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