Job Description

Vice President of Quality Assurance and Regulatory Affairs About the Company Innovative medical device company Industry Medical Devices Type Privately Held About the Role The Company is seeking a VP of Quality Assurance and Regulatory Affairs to serve as the key decision-maker and guide in these critical areas. The successful candidate will be responsible for ensuring that the company's processes, process improvements, and regulatory submissions are conducted with the highest level of accuracy, prudence, and efficiency. This role involves managing the regulatory and quality departments, setting and meeting expectations for schedules, costs, and resources, and maintaining compliance with FDA Quality System Regulations, ISO standards, and other international regulations. The VP will also lead and support various studies, manage regulatory submission activities, and oversee design control and product quality assurance strategies. Applicants for the VP of Quality Assurance and Regulatory Affairs position at the company should have a strong background in regulatory and quality management, with a focus on the medical device or related industry. The role requires a leader who can effectively supervise and develop staff, maintain product consistency, and ensure the company's compliance with all relevant standards. The ideal candidate will have experience in risk management, supplier management, and be adept at handling complaint, failure, nonconformance, and CAPA investigation processes. A high standard of work ethics, professionalism, and the ability to build and maintain productive relationships are essential. The VP will also be expected to represent the company positively and supportively at all times. Travel Percent Less than 10% Functions ~ Medical Care/Hospital Administration Confidential

Job Tags

Similar Jobs