Role Description This role offers a strategic leadership opportunity to shape global regulatory strategy and oversee quality assurance across diagnostic and life sciences products. The VP, Regulatory & Quality will lead cross-functional teams to ensure compliance with international regulations, guide product development, and drive continuous improvement in quality management systems. You will collaborate closely with executive leadership, operational teams, and external partners, influencing regulatory pathways and risk management strategies. This position requires a seasoned leader with deep expertise in regulatory affairs, quality systems, and medical device or diagnostic product commercialization. The role is high-impact, combining technical depth, strategic planning, and team development in a fast-paced, innovation-driven environment. - Lead, mentor, and manage the Regulatory Affairs and Quality Assurance teams, delegating responsibilities and ensuring alignment with corporate objectives. - Develop, implement, and oversee global regulatory strategies to support commercialization, product approvals, and compliance with FDA, CE, ISO, CLIA, CAP, GxP, and other regulations. - Provide regulatory counsel, guidance, and training across all company functions, including product development, Medical Affairs, Legal, and Manufacturing. - Manage preparation, submission, and approval of regulatory filings for US and international markets. - Oversee Quality Management System (QMS) strategy, processes, and continuous improvement initiatives across the organization. - Collaborate with internal teams and external partners to ensure product design, operational changes, and clinical programs meet regulatory and quality standards. - Drive compliance, inspection readiness, risk mitigation, and implementation of quality principles throughout the product lifecycle. Qualifications - BA/BS in Life Sciences required; MS, PhD, or advanced degree strongly preferred. - 20+ years of progressive experience in global regulatory affairs and quality assurance within diagnostics, medical devices, or life sciences technology companies. - Proven experience leading RA and QA teams, with demonstrated ability to develop and implement strategic plans. - Expertise in global regulatory submissions, product commercialization, and lifecycle management, including FDA (510k), CE mark, and other international filings. - Hands-on experience with ISO, CLIA, CAP, CLEP, GxP, and related compliance frameworks. - Strong leadership, coaching, and mentoring skills, with experience guiding teams in cross-functional and high-growth environments. - Excellent communication, negotiation, and strategic planning skills to interact with executive leadership, regulatory bodies, and external partners. - Familiarity with NGS technology, immunology, oncology, or hematology product development preferred. Benefits - Competitive base salary range ($261,000 - $391,600) with bonus and equity eligibility. - Remote work flexibility with occasional in-person collaboration as needed. - Opportunity to lead global regulatory and quality strategy for cutting-edge diagnostic products. - Professional growth through leadership of cross-functional teams and global initiatives. - Comprehensive benefits, including health coverage, professional development support, and equity incentives. - Collaborative, innovation-driven, and inclusive work environment. Company Description

• Establishes and maintains a document management system for regulatory electronic files. • Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. • Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content. • Maintains critical documentation ensuring compliance. • Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA. • Organizes and processes documentation for IRB submission for multiple trials. • Processing of Protocol Deviations that meet the IRB reportable criteria. • Submits urgent safety notifications to the IRB. • Other duties as assigned.

• Lead and manage environmental permitting activities across all company facilities. • Ensure compliance with applicable state and federal environmental regulations. • Oversee preparation, submission, and tracking of environmental permit applications, renewals, and amendments. • Coordinate with internal teams and external consultants to gather data and documentation for permitting. • Maintain up-to-date knowledge of regulatory changes and assess their impact on company operations. • Develop and implement internal procedures to ensure ongoing compliance with environmental permits. • Serve as a liaison with regulatory agencies for environmental permitting matters. • Review and approve environmental reports and documentation prior to submission. • Support environmental audits and inspections; coordinate responses and corrective actions. • Maintain organized records of permits, correspondence, and compliance documentation. • Provide training and guidance to staff on permitting requirements and procedures. • Prepare regular reports for senior management on permitting status and compliance metrics.

• Support the design, implementation, and ongoing maintenance of the organization’s healthcare compliance program in alignment with OIG and DOJ Compliance Program Guidance. • Assist in operationalizing the seven elements of an effective compliance program, including policies and procedures, training, monitoring, auditing, reporting, and enforcement. • Serve as a key resource to internal stakeholders on compliance-related questions and issues, providing guidance to translate regulatory requirements into actionable organizational practices. • Support compliance and quality oversight for Enhanced Care Management (ECM) and Palliative Care programs in alignment with federal, state, and payer requirements. • Monitor regulatory and contractual requirements while tracking evolving guidance impacting program operations, care delivery, and documentation standards. • Conduct audits, monitoring, and QAPI activities, including metric tracking, trend analysis, and support for corrective action plans. • Collaborate cross-functionally to address compliance risks, support audit readiness, and integrate quality and compliance standards into program workflows. • Monitor federal and state healthcare laws and regulations, including but not limited to Anti-Kickback Statute, Stark Law, False Claims Act, HIPAA, and applicable state healthcare regulations. • Track DOJ and OIG enforcement actions, advisory opinions, special fraud alerts, and compliance guidance, and assess applicability to organizational operations. • Conduct compliance risk assessments and help identify, document, and address compliance risks, including fraud, waste, and abuse (FWA), enforcement trends, government oversight, and internal audits. • Support regulatory change management by tracking new or updated laws, regulations, and enforcement trends, including monitoring requirements for potential new markets as the organization expands. • Assist with compliance audits, monitoring activities, and reviews to assess adherence to internal policies and regulatory requirements. • Support internal investigations related to potential compliance concerns, including documentation, issue tracking, and corrective action plans. • Coordinate responses to compliance inquiries, audits, and regulatory requests, as directed by Compliance Leadership. • Maintain investigation and audit documentation in accordance with DOJ and OIG standards and expectations. • Assist in developing and delivering compliance training and education programs for employees, contractors, and leadership. • Promote awareness of compliance reporting mechanisms and non-retaliation standards. • Draft compliance communications, guidance documents, and policy updates, and support implementation of compliance guidance into day-to-day operations. • Maintain organized, audit-ready records. • Collaborate with internal departments to streamline workflows and improve regulatory preparedness. • Stay informed on state and federal regulatory requirements. • Support ad-hoc compliance and quality initiatives, including policy updates, audits, and corrective action implementation, as needed.