Product Compliance Engineer - Onsite
Product Compliance Engineer - Onsite
Join our Product Compliance Systems department as a Product Compliance Engineer for our Royston and Havant site.
We are looking for a Product Compliance Engineer for 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 are looking forward to shaping the future with you.
This position is available on a full-time permanent basis. You will be based on site in Royston, which is a 10-minute walk from the train station and just off A505, making it easy to commute. There will be a requirement to travel to Havant initially on a weekly basis.
Grow with us – Your Responsibilities
1. On a daily basis you will be in close contact with Managing Directors of the two sites, ensuring compliance, providing expertise to the product development team on products from launch to market, being aware of current applicable legal requirements for given products and implementing appropriate regulatory strategies.
2. Act as a consultant during different development projects, interacting between external test laboratories and the engineering team for successful submissions with regulatory authorities.
3. Ensure renewal of approvals or certifications in accordance with changes with certification bodies.
4. Manage technical documentation including risk assessment and correct product labelling.
5. Oversee regulatory inspection, liaising and negotiating with global regulatory and certification authorities (FDA, UKAS, BSI, TÜV).
6. Support continuous improvement initiatives to ensure products and processes comply with regulatory requirements.
What will convince us
1. BSc or Master’s degree in Life Science, Engineering, or a relevant field.
2. Experience with compliance and regulatory affairs in engineering product development, and knowledge of regulatory requirements (FDA, UKAS, BSI, CE marking).
3. Understanding and ability to apply regulatory guidelines/regulations like RoHS directive and low voltage directive (machinery product regulation).
4. Manage activities of European and global market access requirements including NRTL certification (per UL.CSA standards).
5. Experienced in developing innovative strategies and creative solutions within a regulatory context and within the scope of requirements/available resources.
6. Attention to detail and ability to appropriately assess risks.
7. Excellent communication skills, with the ability to influence others and negotiate successful outcomes.
8. Proactive, pragmatic, quick learner, and ability to multitask in a matrix environment.
9. 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
As a growing global life science company, stock listed on the German DAX and TecDAX, Sartorius offers a wide range of benefits:
1. Personal and Professional Development: mentoring, leadership programs, internal seminar offerings.
2. Making an impact right from the start: Comprehensive onboarding, including a virtual online platform – even before joining.
3. Welcoming Culture: Mutual support, team spirit, and international collaboration; communities on numerous topics such as coaching, agile working, and businesswomen network.
4. Health & Well-Being: A wide selection of health and well-being support.
Benefits
Attractive Working Conditions:
1. 37.5 hours working week.
2. 25 days annual leave, plus public holidays.
3. Free parking on site.
4. Annual option to buy, sell, or carry forward annual leave.
5. Free hot and cold drinks.
6. Regular social events and free exercise classes.
1. Competitive benefits package, including:
1. Group Personal Pension Plan.
2. Private Medical Insurance.
3. Private Dental Insurance.
4. Group Life Assurance.
5. Group Income Protection.
6. Cycle to work scheme.
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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