Reports directly to the VP of Pre & Post Market Quality – Molecular. The primary purpose of role is to oversee and manage the product risk management processes within the franchise, ensuring compliance with procedure, and therefore regulatory standards and enhancing the safety and effectiveness of IVD and non-IVD products. The overall objective of the role is to adopt a product risk management framework within the franchises that aligns with the company’s quality management system. This role provides guidance and expertise within a portfolio (and in some cases across portfolios), as subject matter expert regarding Risk Management, Quality Standards, Product Development Risk Process, Product Manufacturing Risks and Controls, and any other Product/System Life Cycle initiatives involving Risk Management. Primary Duties: + Perform all work in compliance with company quality procedures and standards. + Participates in and/or supports the development of R&D Quality Risk Plan(s). + Serves as member of a Core Team or Project team as Global Quality Risk representative. + Owns training modules and performs training for Risk Analysis (Product/Process). + Updates / Approves the product and process risk analyses all along the Product/System Life Cycle + Ensure compliance of assigned products to Product Risk Management internal Processes, and doing so to Standards and Regulations + Stay informed of global regulations related to risk management. + Develop and establish principles of Harmonization and standardization within and across franchises about Product Risk Management Activities with Global Quality Risk BPO. + Guarantee the consistency of the global systems approach and consistency of decisions between the different Life Cycle Management phases + Establish methods to facilitate Risk Based approach in the interest of patients, users, consumers across Product Life Cycle Management + Complete graphs and/or presentations for regular quality updates. + Support an environment of continuous improvement throughout the organization. + Manage improvement project. + Act as a subject matter expert during regulatory inspections and audits, as needed. + Performs other duties as assigned. Supplemental Data: + Ability to work well within a cross-functional team environment. + Capable to complete work in a time-sensitive environment + Able to begin, lead and oversee complex projects independently. Training and Education: Bachelors in related scientific field (e.g. biology, chemistry, bioengineering) and minimum 7 years, or Masters with minimum 6 years experience, or PhD with minimum 4 years experience Experience: + 7+ years in regulatory affairs, R&D or equivalent regulated industry employment position, medical device/IVD industry preferred + 4+ years leading projects Knowledge, Skills, Abilities: Familiar with ISO standards, regulatory requirements (CE/FDA/ QSR). Ability to think strategically, identify and mitigate regulatory risks and maintain regulatory compliant processes and procedures. Must demonstrate strong leadership skills. Personable and service oriented with attention to detail, excellent organizational and time management skills. Excellent written and verbal communication skills. Comprehensive knowledge of regulations applicable to medical device/IVD industry. Must be able to interpret regulatory requirements, determine needs for maintaining compliance, and effectively communicate this information to stakeholders. Ability to influence peers, higher leaders and external expert or regulatory bodies. The ability to work closely with management to identify and communicate areas of technical and timeline risks. #biojobs #LI-US