Executive Director, Regulatory Affairs

Overview

The Executive Director, Regulatory Affairs will manage and provide strategic leadership for regulatory strategy, agency interactions and submissions for IVD products.  The successful candidate will be responsible for developing and implementing regulatory strategy and providing leadership oversight for all regulatory submissions and compliance.  The Executive Director will foster strong relationships and advocacy with FDA and other regulatory authorities and will lead compliance with all relevant regulatory agencies including FDA, CLIA, CAP, CLEP/NY, and IVDR.

Responsibilities

• Collaborate with Chief Laboratory Officer and Chief Regulatory Officer and other key laboratory and business leadership in molecular genetics and oncology.
• Develop regulatory strategy for high complexity molecular testing for oncology, including projects working with both clinical investigators as well as biopharmaceutical partners, ensuring alignment with business objectives and compliance with local and international regulations, including FDA, EU, and other relevant regulatory bodies.
• Represent the company in interactions with regulatory authorities, industry associations, and trade organizations. Build relationships with key stakeholders and actively participate in industry forums and working groups to influence regulatory policies and advocate for the company's interests.
• Work with Quality Assurance personnel and subject matter experts (SMEs) to prepare, review, approve, and submit regulatory documents for molecular oncology tests such as investigational device exemption IDE) applications, study risk determinations, premarket approval (PMA) applications, validation packets for test registration with New York State Department of Health, etc.
• Facilitate interactions with regulatory agencies including written communication, teleconferences, and face-to-face meetings. Work SMEs and different functional groups as needed to ensure quality and content for all correspondence with regulators.
• Prepare and review regulatory submissions, including 510(k) pre-market notifications, PMA applications, CE marking dossiers, and other relevant documentation, ensuring completeness, accuracy, and adherence to regulatory requirements. Liaise with regulatory agencies during the review process and respond to inquiries or requests for additional information.
• Provide regulatory affairs support throughout all phases of product development and commercialization to help ensure upstream activities are aligned with and anticipate regulatory requirements essential for later phases of the product lifecycle.
• Develop an operational Regulatory Affairs group to fulfill routine regulatory needs that arise for production testing, business and product development, and other operational and growth areas of the company.
• Provide leadership, mentorship and coaching to members of the Regulatory Affairs team.
• Foster a culture of regulatory excellence, accountability, and continuous learning, as well as exemplifying Quest’s Purpose and Values.
• Collaborate with cross-functional partners to identify Quest Diagnostics policies / processes / procedures that may be affected by regulatory changes and ensure alignment on regulatory objectives, initiatives, and priorities.
• Partner with Legal, Quality, and Regulatory counterparts across the organization as required.
• Monitor and analyze regulatory trends, changes, and competitive landscape in the diagnostics industry. Assess the impact of regulatory changes on the organization's existing and future products and develop proactive strategies to ensure compliance and competitive advantage.

Qualifications

• A Bachelor’s Degree in a Life Science-related discipline is required. An advanced degree is strongly preferred. 
• A minimum 15 years of experience in Regulatory Affairs within the diagnostics industry with 5 years of leadership and management experience.
• Experience leading, designing, writing and submitting regulatory filings.
• Strong experience in ISO, CLIA, CAP, CLEP, GDPs and other Regulatory compliance requirements.
• A track record of successful regulatory submissions and approval of global regulatory filings and reporting for US (510(k)) and other key countries/regions, including CE marks.
• Excellent oral, written, and interpersonal communication skills.
• Demonstrated ability to influence, create, and drive change, and the ability to build cross-functional relationships and work collaboratively.
• Demonstrated success in motivating team members to reach objectives, and the ability to build followership across organizational boundaries and navigate/collaborate in a complex, highly-matrixed organization.
• Strong project/team management skills, and the ability to effect continuous improvement actions through problem solving skills and knowledge of quality tools.
• Flexibility to meet continuously changing priorities and challenges.
• The ability to travel 25-50% is required.

EEO

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets