Major Medical Device Provider and Leader in its field for over 70 years seeks a Senior Manager, Risk Management to lead the execution of the global medical device risk management strategy in order to achieve products of high quality and maintain compliance to medical device risk management standards and regulations.
The Senior Risk Management Manager will be responsible for RM Quality System for external and internal partners, auditing bodies and inspections. This individual will develop a long-term strategy for the Risk Management process, ensure implementation and maintenance of the system and strive for continuous improvements.
- BS or higher degree in Life Sciences or Engineering.
- Minimum of 5 years of experience with medical product or in process development environments.
- 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.
- Develops and implements the Risk Management strategy for and be 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 requiredrisk management deliverables and ensuring the post-market information of similar products feedback to the new product development cycle.
** This opening requires that candidates have either a Green Card or US Citizenship **