The Senior Director Regulatory Affairs and Quality Systems Management is part of the Compliance organization and reports directly to the Chief Compliance and Regulatory Officer. This position is accountable for providing leadership and direction in the implementation of regulatory strategy for Patterson (“Company”) ensuring that the Company's operations comply with domestic and international regulations and company policies.
Establish and maintain harmonized global regulatory management systems designed to effectively and efficiently support business objectives
Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives, while ensuring compliance with domestic and international regulations
Provide interpretation and training of domestic and international regulatory requirements to the Company
Collaborate with VP, Regulatory Operations to ensure compliance across all regulatory matters
Implement and maintain processes and systems to ensure accurate, complete and timely submissions to regulatory agencies to meet business objectives.
Anticipate and assist in the resolution of regulatory and/or quality issues and potential non-compliances and recommend corrective action.
Establish and maintain an information network for purposes of monitoring changing and developing domestic and international regulatory environments, followed by appropriate preventive communication and training.
Establish and maintain a process to participate in the review of process/product changes, labeling, claims, complaints, etc., to determine the need for regulatory submissions and to ensure compliance to FDA and international requirements.
Serve as a liaison internally as well as externally with FDA.
Provide leadership to ensure the Regulatory Affairs organization attracts, develops and retains the best people and fosters an environment that motivates a diverse team to fully use its capabilities in achieving desired business results.
Communicate and coordinate international regulatory activities with other departments.
Continuously lead change & improvement; regularly assess effectiveness of the regulatory and quality programs and develop and implement enhancements to continuously improve the program.
Performs Due Diligence and Integration activities related to mergers and acquisitions.
Direct the development, implementation and maintenance of the Company's global Quality System. Specific functional areas include: Strategic Planning; Design Control; Risk Management; Product and Process Change Control; Document Control; Management Reviews; Quality Training Systems
Lead the development, implementation and optimization of a right-sized quality system to meet the Company's obligations related to FDA-regulated software and private label products
Responsible for ensuring multi-site processes adherence to applicable quality system regulations, consensus standards and corporate policies through training, documentation control, and CAPA's
Directs activities required in the management of the Quality Management System, including implementing a Quality Manual to ensure compliance and facilitate efficient business operations.
Directs the Management Review process and serves as the Management Representative for the Quality System.
Leads the Quality Strategic Planning process and measures and inspects progress to plan.
Maintains current knowledge base of regulations, corporate policies, and standards to ensure compliance.
Integrates the Quality System into Merger and Acquisition activities.
Keeps the Compliance Officer apprised of issues.
Encourage the growth of all direct and indirect reports through skill development and goal setting.
Hold direct reports accountable for meeting performance standards and departmental performance goals.
Mentor staff, measure performance, and complete regular performance reviews.
Resolve employee issues in an effective and consistent manner.
Manage the Regulatory Affairs and Quality Management budget.
Develop a highly motivated staff that is organized and structured to most effectively utilize individual and group capabilities.
Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported and manage teams and self in accordance with the expected behaviors of the Leadership Qualities to facilitate creativity and innovation, personal growth and business contributions of a diverse work force. Regularly provide feedback, coaching and performance management.
Performs other tasks as required under the direction of the Chief Compliance and Regulatory Officer
MBA or advanced degree preferred; MS in Sciences / Regulatory Affairs, Engineering or Clinical Medicine a plus
10+ years of experience in domestic FDA submissions [510(K)] and an in-depth working knowledge of FDA regulations specific to software, as well as international medical device regulations and requirements
Minimum of 7 years related leadership/management experience, including budget responsibility, with staff of similar size and technical level.
Experience with GMP (QSR) a plus
Experience should include close working relationships with business, marketing, development, legal and research functions, and an in-depth knowledge of domestic and international medical device and drug regulations and ISO 13485 quality requirements.
Experience with EU and/or other international medical device regulations and submissions preferred.
Experience as primary liaison to international regulatory authorities as well as experience authoring, reviewing and managing components of regulatory submissions is required.
Ability to think strategically and critically evaluate risks to regulatory and quality activities.
Experience in a matrix organization and ability to negotiate across functional boundaries.
Ability to influence supervisors, peers, and subordinates to drive innovation initiatives.
Very strong communication skills (verbal and written); ability to explain technical information to non-technical people.