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 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.