2 days old

Senior Director, Quality & Regulatory Affairs-Division

Elkton, MD
  • Job Code
JobId: 381430
JobTitle: Senior Director, Quality & Regulatory Affairs-Division
Department: Regulatory Affairs PSD
Location: Terumo CV Group Elkton, MD
Description: This position is responsible for providing oversight of all Quality and Regulatory Affairs functions within a division of Terumo Cardiovascular, including but not limited to: product safety, regulatory strategy and execution, investigation of serious incidents, improving product quality through complaint investigation, resolution, CA\/PA management, internal auditing, and acceptance activities. Position is responsible for all elements of the Division Quality System and maintaining compliance with all applicable worldwide standards and regulations.
1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
2. Ensure that quality and regulatory compliance activities are a properly resourced and prioritized across the organization.
3. Design and implementation of Quality Policies and Procedures for division wide quality and regulatory affairs.
4. Coordinate with Manufacturing to plan, develop, organize, implement, direct and evaluate the impact of proposed global regulatory and quality changes to current manufacturing processes and impact to market.
5. Lead the decision-making process concerning departmental policies for the Quality and Regulatory functions.
6. Responsible to execute the Regulatory and Quality planning and strategy for the Division in alignment with the TCVS Annual and Long Range Plans.
7. Establish, implement and maintain the QS and Product Registration audit program including trending key compliance issues at each location.
8. Monitor key indicators of the Quality System and status of global product registrations at each site for corrective and preventative action changes.
9. Implement the quality and regulatory team goals and objectives for continual improvement of the efficiency and effectiveness of the group and provide individuals with professional and personal growth. Maintain current knowledge of global medical device regulations, , participates in decision-making concerning policies, regulatory requirements and strategies. Determine appropriate action to take regarding product field actions.
10. Utilize the systems and processes in place to attract, develop, engage, train and retain talented Associates; create a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
11. Perform other duties as assigned.


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Senior Director, Quality & Regulatory Affairs-Division

Elkton, MD

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Elkton, MD

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