Cypress HCM · 18 hours ago
Director of Clinical Affairs
Tustin, CA
Contract
Onsite
Lead/Staff, Director/Executive
$180K/yr - $210K/yr
3+ years expCypress HCM is a growing company focused on precise, early detection of emerging diseases. The Director of Clinical Affairs is responsible for managing clinical trial execution and regulatory submissions to support IVDR and FDA authorization, while contributing to diagnostic programs and ensuring compliance with regulatory requirements.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
Define and execute the clinical strategy for current and future diagnostic programs, including study prioritization, timelines, budgets, and evidence-generation plans aligned with regulatory, commercial, and reimbursement objectives
Directly contribute to protocol and statistical analysis plan development, study start-up and execution, site selection, and day-to-day coordination of clinical operations with CROs, clinical sites, and investigators
Ensure clinical data collection, monitoring, and management meet regulatory and scientific requirements (e.g., GCP, ISO 14155)
Lead post-market clinical follow-up and real-world evidence (RWE) activities to support market expansion and lifecycle management
Own and execute the global regulatory strategy for all diagnostic products, including planning, preparation, and sequencing of IVDR, FDA, and state-level submissions
Act as the primary point of contact with regulatory consultants, agencies, and notified bodies, managing submissions, deficiency responses, audits, and ongoing communications
Ensure continuous regulatory compliance across clinical, laboratory, and diagnostic operations
Partner closely with Quality and Laboratory teams to maintain compliance with CAP/CLIA, ISO 13485, and IVDR requirements
Lead the design and execution of clinical and health economics studies to support payer coverage and reimbursement strategies
Work hands-on with market access, health economics consultants, and external advisors to develop evidence demonstrating clinical utility and cost-effectiveness
Support authorship and development of publications, dossiers, and white papers to drive payer and physician adoption
Provide hands-on clinical, scientific, and regulatory input throughout product development and to senior leadership
Support research collaborations, grant submissions, and publications
Build, mentor, and guide Clinical & Regulatory Affairs team members, contributing directly while scaling capabilities
Qualification
Required
Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field; Master's a plus
3+ years of laboratory experience, including experience with audits, compliance systems, and regulatory submissions
Strong knowledge of key regulations and standards: FDA QSR (21 CFR Part 820/211), ISO 13485/9001, EU MDR/IVDR, GMP, ICH guidelines, etc
Working knowledge of relevant regulatory frameworks
Proven knowledge of quality assurance terminology, software, methods, and tools
Strong analytical, problem-solving, and decision-making skills
Experience in compliance and/or regulatory and knowledge of laboratory standards and regulations
Experience with Microsoft Office Suite; Word, Outlook, Excel
Excellent written and verbal communication skills for agency interactions, technical writing, and cross-functional collaboration
Able to effectively present information and respond to questions from various stakeholders
Preferred
Professional certification is a plus (i.e, Regulatory Affairs Certification – RAC, ASQ Certified Quality Auditor – CQA)
CLS Generalist or CGMBS license preferred
Previous experience with Laboratory Information Management Systems is preferred
Proficient in QMS software (i.e. MediaLab, TrackWise, MasterControl or similar)
Company
Cypress HCM
Cypress HCM is a staffing and recruiting company providing technology and creative recruiting solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mark Lillig
CEO
Philip Oommen
CFO
Company data provided by crunchbase