Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
POSITION PURPOSE: The Senior Manager, Risk Management (RM) leads the execution of the global medical device risk management strategy for the Ascensia Diabetes Care products throughout their lifecycle in order to achieve products of high quality and maintain compliance to medical device risk management standards and regulations.
The Senior RM Manager is the main contact for RM Quality System for external and internal partners, auditing bodies and inspections. The jobholder of this position needs to develop a long-term strategy for the Risk Management process at Ascensia, ensure implementation and maintenance of the system and strive for continuous improvements.
Major Tasks and Responsibilities of Position
Develops and implements the Risk Management strategy for ADC and is responsible for ensuring that requirements in international standards and regulations are identified and implemented in relevant procedures.
Represents Risk Management function to provide expertise across the product and process projects. Provides guidance to project teams in terms of compliance of specific requirements of risk management standards and regulations throughout the product lifecycle and corporate processes.
Manages cross functional teams to ensure timely preparation and organization of approval of post-market surveillance reports and annual product statement.
Collaborates with cross functional teams to ensure timely preparation and organization of approval of health risk assessment upon an adverse event identified.
Provides advice, counsel and recommendations to the organization concerning risk management matters and strategies for new product developments and marketed products.
Assures new product developments are in compliance with requirements and regulations by developing or reviewing required risk management deliverables and ensuring the post-market information of similar products feedback to the new product development cycle.
BS or higher degree in Life Sciences or Engineering.
Minimum of 5 years of experience with medical product or in process development environments. Experience with diabetes products is highly desirable.
Must be able to demonstrate significant knowledge and understanding of Quality Assurance and Regulatory processes and proficiencies. Ideal candidate will have a detailed working knowledge of ISO 14971, ISO 13485 and ISO 62304. Training or certification of a quality auditor, risk management and/or quality engineer is highly desirable.
Must have strong ability to direct and lead key activities in functional areas in order to successfully implement responsibilities and accomplish objectives.
Must have broad technical, process, and organizational skills to maximize functional capability and performance.
Must have excellent influencing skills to lead individuals for whom the incumbent does not have a direct reporting relationship.
Must possess excellent interpersonal, written and verbal, communication skills.
Demonstrates a proficiency for using new technologies to improve efficiencies within the organization.
Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.
TO ALL RECRUITMENT AGENCIES:
Ascensia does not accept unsolicited third party resumes.
Ascensia is an Equal Opportunity Employer.