VP of Quality & Regulatory Affairs (Q&RA) will develop, implement and maintain a comprehensive Quality & Regulatory Affairs system in accordance with regulatory/accrediting requirements. The Director of Q&RA will be a highly participative leader, responsible for the hands–on management and direction of Quality Assurance and Regulatory Affairs implementing “best practices”, continuous improvement and corrective/preventive actions as necessary. The VP is responsible for ensuring that processes and initiatives are compliant with all applicable external standards and regulatory requirements and all applicable policies, initiatives and procedures, as well as successfully interacting with and managing relationships and compliance with approval agencies such as the US FDA, Heath Canada, etc.
- Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs. Ensures that processes and standards comply with all relevant quality standards and regulations; conducts continuous improvement reviews/audits with regards to all relevant policies/procedures and implements corrective action as necessary.
- Manages, coordinates and administers all functions of the Q&RA function to achieve company compliance and objectives and demonstrate continuous improvement. Provides constructive and relentless guidance in finding solutions for resolving quality concerns and driving improved efficiencies and on-going continuous improvement. Ensures Quality input into and the monitoring of the processes in relation to quality and compliance.
- Develops and leads a quality and regulatory staff with the skills and abilities to ensure quality products and regulatory compliance for North America. As required, hires, terminates, evaluates and disciplines employees in accordance with current personnel policies, including performance management and performance improvement plans. Regularly leads and monitors employees’ performance to assure that departmental goals and objectives are met. Ensures that staff is adequately trained and responsive to end user needs and complies with all regulatory/accreditation requirements.
- Oversees Complaints investigation, MDRs, Corrective and Preventive Action (CAPA), HHE/HARM, Supplier Development/Quality and other related processes, including investigations, resolving quality concerns and issues and maintaining all required documentation. Works with Product Management and R&D and Production to define and improve product specifications and develop vendor specifications and standards to provide customers with the safest and best quality performing product possible.
- Manage, and establish / maintain compliance with FDA QSRs and other global regulation as applicable. This includes, but is not limited to, timely registration of establishments and listing of devices for all facilities and outsource partners, development and submission of regulatory requirements for product projects, submission of premarket notifications in accordance with FDA and foreign regulatory body requirements, license renewals, initial and annual product reports, etc.
- As the organization’s official contact/liaison for all regulatory matters, establish and maintain positive relationships with government agencies and other regulatory authorities and represent the organization in matters before such agencies and authorities so that the organization’s goals and objectives are advanced. This includes the management of approved field corrections/product removal activities, filing of MDRs, maintenance of Regulatory Affairs files and regulatory correspondence and all related activities.
- Represents the business during any inspection/audit processes, internal or external. Implements appropriate activities to ensure regulatory compliance and adherence to the quality system. Serves as the official correspondent to the FDA and ISO regulatory/accrediting bodies. Monitors, interprets and communicates federal regulation and external changes in the regulatory environment to ensure continued compliance of the quality system in all facilities.
- Communicates with all functional groups to ensure awareness of regulatory and quality requirements. Provides and/or coordinates company-wide quality and regulatory training. Provides monthly updates to senior leadership and gains alignment on recommended changes.
- Other duties and projects as required and assigned by Executive leadership, MUST BE WILLING TO BE HANDS-ON!
- Bachelor’s degree in a technical field from four-year college or university or equivalent combination of education and experience in a medical device regulated industry with minimum of 10 years of progressive management experience in a responsible quality assurance/regulatory role. RAC or ASQ certification a plus.
- Experience working in a disciplined, regulated industry/medical device environment with quality systems associated with development, manufacture and support of medical devices.
- Proven leadership in formulating and implementing strategies to ensure product quality and compliance with US and international regulations.
- Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessment or inspection.
- Ability to apply current inspectional techniques to project documentation during the product lifecycle and prior to FDA or other regulatory inspections to ensure compliance.
- Ability to work professionally with highly sensitive information and maintain confidentiality.
- Demonstrated effective communication skills including writing and presentation skills.
- A perfectionist with attention to detail – a hands-on “fixer” who continuously strives for excellence. The ability to inspire others to adopt this mentality of prioritizing quality and compliance above all else. Willingness to be directly involved in all tactical and administrative aspects of the position.
- High energy leader with the ability to manage multiple and varied tasks with enthusiasm; can prioritize workload and constructively interact and negotiate with a range of personalities and many levels of the organization and external entities; achievement oriented and customer focused