Product Risk Manager

Job Title Product Risk Manager Job Description Job title: Product Risk Manager Your role: Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development and during lifecycle management of product per ISO 14971 and product specific regulations and standards. Monitors and reports on the product safety risk management performance in the field and ensures deliverables are updated as needed. Ensures the appropriate risk assessments are performed per risk management procedures. Defend Risk Management and design quality activities during external and internal audits. Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule. Evaluate process and product changes for their impact to the current Risk Management Files. Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files Work with global experts to drive the common practice and best practice across sites for risk management, design regulations compliance and business requirements Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above Makes a fundamental contribution to the innovation of products or processes. Solves fundamental problems on the basis of thorough (unique) knowledge in the professional field. Solves technical problems that have never been encountered previously in the organization. Generates initiatives with regard to technological improvements and performs future-oriented studies in dialogue with other specialists. Makes substantial contribution to the innovation process and communicates new insights to own business. . You're the right fit if: (4 x bullets max) Minimum 3 years of experience with Vocational Education in System Architecture, System Design, Hard