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 strategies You will provide product regulatory compliance input to strategic decision making, including review, prioritization, risk assessment and external communications You will support the development and deployment of global policies and standards You will manage tests with external laboratories as well as successful submissions with regulatory authorities You will plan, undertake and oversee regulatory inspections, liaise and negotiate with global regulatory and certification authorities You will provide advice about regulations to project team members and will review and report overall quality status You will keep up-to-date with changes in regulatory legislation and guidelines You will support your direct manager with continuous improvement initiatives to ensure the products and processes comply with regulatory requirements Perform 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 required Several years relevant experience within the Regulatory Affairs discipline and deep knowledge of the relevant Regulatory requirements Thorough 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 benefit Experienced in developing innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources Proven analytical skill and technical/scientific competence Attention to details and ability to appropriately assess risks Excellent communication skills, with ability to influence others and negotiate successful outcomes Proactive, pragmatic, quick learner and independent worker able to effectively multi-task in a strongly growing organization Proven ability to effectively work collaboratively in cross functional teams Excellent written and verbal communication skills and fluency in English Über Sartorius Sartorius ist Teil der Lösung im Kampf gegen Krebs, Demenz und viele andere Krankheiten.
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