Director, Regulatory Affairs

Reporting to the Company's Chief Operating Officer, the Director, Regulatory Affairs is responsible for providing regulatory leadership, quality systems support, and other hands-on functional expertise to support CND's growing portfolio of cutaneous neurodiagnostic products (currently classified in the US as laboratory developed tests). The Director has significant experience developing regulatory strategies for medical device, in vitro diagnostics, and/or software-based medical products for US and EU markets and has led successful 510K and CE-marking processes. In the immediate term, the Director will work with outside consultancies to help CND satisfy the Medical Device & In Vitro Diagnostics regulatory requirements for the EU and serve as the primary point of contact for all related activities (including interfacing with the EU notified bodies). For the US, the Director will help establish processes that support and complement existing laboratory quality systems standards for both the commercial testing and research testing operations and lead efforts to prepare for potential regulatory changes in the future assuming CND's products may move from a laboratory developed test (LDT) designation to a Medical Device/In Vitro Diagnostics classification governed by FDA. Overall, the Director is responsible for day-to-day operational implementation of activities for regulatory compliance across the company with close collaboration with personnel responsible for specific elements of the laboratory quality system. Additionally, the Director oversees and directs the work of outside regulatory and quality consultants to achieve desired outcomes.

Job Responsibilities:

General Duties

• Serve as the Company's leading authority on US and EU regulatory strategies and requirements for its portfolio of cutaneous neurodiagnostic products. Work closely with Company executives, including COO, CEO, CMO, CSO, head of quality, and other roles, to develop effective regulatory plans to achieve corporate goals.
• Responsible for establishing the strategic roadmap for regulatory clearance of products moving through the R&D pipeline. Meet regularly with key commercial and R&D leaders to assess product and technology directions and offer recommendations on potential regulatory considerations for the US and EU markets.
• Represent the Company in interactions with regulatory authorities. Play a prominent role in complex negotiations regarding the Company's regulatory strategy for product submissions, including but not limited to (1) clinical and analytical study designs and performance data presented during the pre-submission phase and (2) acceptable claims, wording, performance data and other information at the pre-clearance/approval phase.
• Work with outside consultancies when necessary and organize and manage meetings with regulators, including development of agendas and training/preparation of company personnel attending these meetings.
• Collaborate regularly with the Company's head of quality on all laboratory quality requirements, quality manual, quality system, and compliance with laboratory-specific agencies including CLIA and CAP. Work together to achieve appropriate ISO certifications.
• Interpret statutes, regulations, policies and guidelines for business teams and product development/support teams, communicating the impact on product development, manufacturing, and/or marketing.
• Independently manage and monitor multiple complexes, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision. Maintain a "focused urgency" as required by specific events.
• Work closely with the quality team to maintain all necessary documents in an effective manner.
• Other duties as assigned.

EU and International Markets

• In collaboration with CND leadership and outside expert consultants, help develop regulatory strategies for product commercialization in the EU and other defined international markets including Brazil, Canada, UK, and Mexico.
• Work with Company leaders to establish ISO certification and other required protocols to satisfy health regulatory requirements in international markets.
• For EU MDR and IVDR requirements, in collaboration with outside consultants, prepare technical documentation for CE marking. Obtain information and support from Quality, Laboratory Operations, R&D, Medical Affairs, and other functions.
• Develop and oversee processes for the Company to maintain high standards of quality and regulatory compliance in collaboration with Quality leaders in the organization.
• Interface as needed with Notified Bodies regarding significant changes to products.
• Provide subject matter expertise during Technical Audits by Notified Bodies to maintain design certificates.

US Market

• Work with Company leadership to develop near and long-term regulatory strategies as the product portfolio evolves. Seek input from outside consultants and regulatory attorneys to define and confirm potential pathways with FDA.
• In collaboration with the Company's laboratory, quality and pathology leadership, help maintain relations and compliance with laboratory regulatory and certification bodies including CLIA, CLEP and CAP.
• Prepare or coordinate the preparation of Q-submissions, 510(k) and/or PMA submissions to FDA.
• Provides risk assessments of strategies and regulatory options to cross-functional business teams and to product development/support teams.
• Work closely with quality, laboratory operations, pathology and R&D leaders to maintain quality systems, monitor performance, implement corrective actions and improve processes.
• Stay on top of all FDA requirements, guidance, and developments related to IVD and LDT products.

Knowledge, Skills & Experience:

• 10-15 years of quality and regulatory experience with an international medical device or medical diagnostics company; experience with companion diagnostics highly preferred
• 5+years of experience interfacing directly with regulatory and/or accrediting agencies (must include FDA and European notified bodies) including hosting/performing inspections, providing responses to regulators, etc.
• Experience in building and managing regulatory teams and leading cross-functional project teams on collaborative projects.
• Technical knowledge of regulatory requirements, including but not limited to FDA-IVD, EU-IVDR, and ISO
• Ability to interpret and apply government and industry regulations
• Experience in the preparation and filing of regulatory submissions for medical device or medical diagnostics company
• Ability to analyze, define and effectively convey difficult and complex issues in a way that accurately communicates the issues to leadership and external business partners.
• Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills
• High level of initiative and excellent collaboration skills to facilitate cross-functional projects.
• Ability to problem solve and make decisions on complex issues, often in a cross-functional team setting.
• Strong organizational and planning skills as well as strong attention to detail
• Ability to work independently with limited supervision, adapt to change and manager multiple tasks
• Strong skill in the Microsoft Office Suite and working knowledge of electronic publishing/file management
• Strong familiarity with and use of document control systems

Education, Certifications & Licensures:

• Bachelor's degree in a science related field required
• Relevant RAPS and ASQ professional development and certifications required (with ongoing support from the Company)

Special Training:

• Fulfill the Company's manager training related to the Company's products, scientific foundation, and other areas

Other:

• This position is based at the Company's Scottsdale, Arizona headquarters with the expectation of performing work on site, in-office a minimum of 3-4 days per week.
• Other preferred locations that will be considered are Atlanta and Boston
• Other geographical exceptions and remote working may be made for exceptional candidates.

Physical Demands:

• Ability to use copiers, fax machines, and PDF scanners to keep inventory and ordering records. Visual acuity and analytical skill to distinguish sufficient detail.
• Must possess the ability to sit or stand for long periods.
• Must possess the ability to perform repetitive motion.
• May have exposure to biohazardous material in the lab environment