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