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Join our Product Compliance Systems department as a Product Compliance Engineer for our Royston and Havant site.
We are looking for a Product Compliance Engineerfor the Product Compliance Systems department at Sartorius. 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. You will organize product specific regulatory requirements, oversee required tests, facilitate risk assessment, track and control submissions, provide guidance and advise internal stakeholders for our Royston (Hertfordshire) and Havant (Hampshire) site. The team consists of 5 professionals, and we arelooking forward to shaping the future with you. This position is available full - time permanent basis. You will be based on site in Royston and the site is 10 minutes' walk from the train station and is just off of A505 so it's easy to get to with the requirements to travel to Havant initially on a weekly basis. Grow with us - YourResponsibilities
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, TUV) 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
In order to commence working with us, the successful candidate will have the right to work in the UK. What we offer Asa growing globallife science company, stock listed on the German DAX and TecDAX, Sartorius offers a wide range of benefits:
Personal and Professional Development: mentoring, leadership programs, internal seminar offerings Making an impact right from the start: Comprehensive onboarding, including a virtual online platform-even before joining Welcoming Culture: Mutual support,team-spirit and international collaboration; communities on numerous topics such as coaching, agile working and businesswomennetwork Health & Well-Being: Wide section of health and well-being support such as
Benefits Attractive Working Conditions:
37.5 hours working week 25 days annual leave, plus public holidays Free parking on site Annual option to buy, sell or carry forward annual leave Free hot and cold drinks Regular social events and free exercise classes
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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Sartorius North America
medical insurance, dental insurance
Feb 17, 2025