Senior Director, Regulatory Affairs (Remote)

The Senior Director, Regulatory Affairs will manage and provide tactical leadership for regulatory strategy, agency interactions and submissions for IVD products. He/she will be responsible for developing and implementing regulatory strategy and providing leadership oversight for all regulatory submissions and compliance. The successful candidate 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.

• 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.
• Develops and updates global, regional, and multi-country regulatory strategy and seeks opportunities for innovative approaches to meeting regulatory requirements.
• Establishes working relationships and interfaces and with government and non-government organizations having an impact on market access and distribution.
• Distributes and implements regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
• Identifies the need for and manages the development, approval, and execution of new regulatory procedures and standard operating procedures (SOPs).
• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Identifies regulatory pathways for initial product designs and collaborates with internal stakeholders to determine the final regulatory strategy.
• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite product development.
• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans.
• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
• Provides strategic input and technical guidance on global regulatory requirements to product development teams.
• Evaluates risks of product and preclinical and clinical safety issues during clinical phases and recommends regulatory solutions.
• Leads cross-functional teams for interactions with regulatory authorities including panel meetings/ advisory committees.
• Provides regulatory guidance on strategy for proposed product claims and labeling.
• Ensures that the clinical and nonclinical data- in conjunction with organizational objectives -are consistent with the regulatory requirements and support the proposed product claims and labelling.
• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
• Leads key negotiations and interactions with regulatory authorities during critical stages of the development and review process.
• Reviews and approves change controls to determine the level of change and consequent submission requirements, assesses potential impact on business objectives, and communicates that impact accordingly.
• Develops, implements, and manages systems to track required reports, supplemental submissions and other post-marketing commitments.
• Leads integrated regulatory process and system improvement initiatives that will influence and build new capabilities for greater effectiveness and efficiencies.
• Represent the organization with thorough understanding and communication of legislation, regulations, guidance, policy, and directives.
• Evaluate corporate policies to mitigate regulatory risk to ensure adequate compliance to help the company achieve its business goals.
• Manages or leads the process that monitors updates on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory issues.
• Proactively manages and monitors progress against desired outcomes including working with others to establish and adjust contingency plans, revising and adapting processes, communicating success, and learning from mistakes.
• 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, premarket approval (PMA) applications, validation packets for test registration with New York State Department of Health, etc.
• 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.
• Monitor and analyze regulatory trends, changes, and competitive landscape in the diagnostics industry.
• Contributes to the development, operationalization and execution of regulatory internal practices.
• Assess the impact of regulatory changes on the organization's existing and future products and develop initiatives and strategies to ensure compliance and competitive advantage.

• A Bachelor's degree in a Life Sciences-related field is required. An advanced degree is preferred.
• A minimum of 10 years of experience in Regulatory Affairs within the diagnostics industry, with at least 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.
• Record of a successful regulatory submission and approval of global regulatory filings and reporting for US (510(k)) and other key countries/regions, including CE marks.
• Excellent oral and written communication skills and ability to build cross-functional relationship and work collaboratively.
• The ability to travel up to 25% is required.

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