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

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 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.