Product Compliance Expert will be responsible for ensuring and executing the product regulatory compliance of Instruments and Systems during development and life cycle management (product maintenance / changes) for launch readiness.

Product Compliance Expert will be responsible for ensuring and executing the product regulatory compliance of Instruments and Systems during development and life cycle management (product maintenance / changes) for launch readiness.
You will organize regulatory information for the assigned countries/regions, oversee required tests, facilitate risk assessments, track and control submissions, provide guidance and advice to internal stakeholders.

Main Responsibilities & Tasks:

You will manage the activities of product compliance of assigned projects/products within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategiesYou will provide product regulatory compliance input to strategic decision making, including review, prioritization, risk assessment and external communicationsYou will support the development and deployment of global policies and standardsYou will manage tests with external laboratories as well as successful submissions with regulatory authoritiesYou will plan, undertake and oversee regulatory inspections, liaise and negotiate with global regulatory and certification authoritiesYou will provide advice about regulations to project team members and will review and report overall quality statusYou will keep up-to-date with changes in regulatory legislation and guidelinesYou will support your direct manager with continuous improvement initiatives to ensure the products and processes comply with regulatory requirementsPerform regulatory compliance assessment for assigned products to ensure the compliance in target market and maintain compliance based on assessment
 

Qualification & Skills:

Bachelor´s  or Master's degree in science within a relevant scientific discipline requiredSeveral years relevant experience within the Regulatory Affairs discipline and deep knowledge of the relevant Regulatory requirementsThorough understanding and demonstrated ability to apply Regulatory guidelines/regulations like Chinese pressure vessel regulation (TSG 21-2016)Manage the activies of APAC market access requirements，including China CML certification，CCC，RoHS，DOSH，KCs，etc Knowledge of global certification requirements would be an added benefitExperienced in developing innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resourcesProven analytical skill and technical/scientific competenceAttention to details and ability to appropriately assess risksExcellent communication skills, with ability to influence others and negotiate successful outcomesProactive, pragmatic, quick learner and independent worker able to effectively multi-task in a strongly growing organizationProven ability to effectively work collaboratively in cross functional teamsExcellent written and verbal communication skills and fluency in English

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