Product Compliance Expert (x|w|m) – Hybrid

We are looking for a Product Compliance Expert (x|f|m) for the Product Compliance Systems department at Sartorius Stedim Systems GmbH.
In this role, you will be responsible for ensuring product regulatory compliance is in place for Instruments and Systems during product development and life cycle management for product launches.
This position is available for full-time. It is a hybrid role requiring some days on site at our site in Guxhagen with the opportunity to work some days remotely.

Grow with us – Your Responsibilities

• On a daily basis you will be in close contact with Managing Directors of the two sites, ensure sites are compliant, provide expertise to the product development team on products from launch to market, being aware of current applicable legal requirements for given products and implement appropriate regulatory strategies

• Act as a consultant during different development projects, interact between external test laboratories and engineering team for successful submissions with regulatory authorities

• Ensure renewal of approvals or certifications in accordance with changes with certification bodies

• Manage technical documentation including risk assessment and correct product labelling

• Oversee regulatory inspection, liaise and negotiate with global regulatory and certification authorities (FDA, UKAS, BSI, TÜV)

• Support continuous improvement initiatives to ensure product and processes comply with regulatory requirements    

 What will convince us

• BSc or Master’s degree in Life Science or Engineering or relevant field

• Experience with compliance, regulatory affairs in engineering product development and knowledge of regulatory requirements (FDA, UKAS, BSI, CE marking)

• Understanding and ability to apply regulatory guidelines/regulations like RoHS directive, low voltage directive (machinery product regulation)

• Manage activities of European and global market access requirements including NRTL certification (per UL.CSA standards)

• Experienced in developing innovative strategies and creative solutions within regulatory context and within the scope of requirements/available resources

• Attention to detail and ability to appropriately assess risks

• Excellent communication skills, with the ability to influence others and negotiate successful outcomes

• Proactive, pragmatic, quick learner and ability to multitask in a matrix environment

• Ability to collaborate in a cross functional environment

What we offer

As a growing global life science company, stock listed on the DAX and TecDAX, Sartorius offers a wide range of Benefits:

• Personal and Professional Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings

• Work life balance: Remote options, flextime, flexible work schedules

• Attractive compensation: Vacation and holiday bonuses including pension benefits with a 37.5 hr. week and 30 vacation days

• Making an impact right from the start: Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as point of contact

• Travel benefits: car leasing, bike leasing, large free parking garage, good bus connections

• Welcoming Culture: Mutual support, teamspirit and international collaboration; communities on numerous topics, such as coaching, agile working and business women network

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