Cypress HCM
This is an exciting opportunity to join a growing company that focuses on precise, early detection of emerging diseases. The Director of Clinical Affairs is responsible for the day-to-day planning and execution of clinical and regulatory activities across the diagnostic portfolio. This role directly manages clinical trial execution and regulatory submissions to support IVDR and FDA authorization and enable market access, while also contributing to diagnostic programs.
This is a highly hands-on role suited for a self-driven professional who thrives in a lean environment. The Director will personally drive timelines, prepare and review submissions, coordinate vendors and study sites, and solve operational challenges with limited resources. The role works closely with the Chief Scientific Officer and a Clinical Trial Project Manager to ensure efficient, compliant execution of clinical and regulatory programs.
Responsibilities
Clinical Strategy & Execution: 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.
Regulatory Affairs: 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.
Reimbursement & Market Access: 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.
Other Responsibilities: 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.
Requirements and Desired Experience
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
Professional certification is a plus (i.e, Regulatory Affairs Certification – RAC, ASQ Certified Quality Auditor – CQA).
CLS Generalist or CGMBS license preferred
Proven knowledge of quality assurance terminology, software, methods, and tools.
Previous experience with Laboratory Information Management Systems is preferred.
Proficient in QMS software (i.e. MediaLab, TrackWise, MasterControl or similar)
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
Compensation (DOE):
$180,000 - $210,000 annual salary
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Responsibilities
Clinical Strategy & Execution: 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.
Regulatory Affairs: 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.
Reimbursement & Market Access: 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.
Other Responsibilities: 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.
Requirements and Desired Experience
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
Professional certification is a plus (i.e, Regulatory Affairs Certification – RAC, ASQ Certified Quality Auditor – CQA).
CLS Generalist or CGMBS license preferred
Proven knowledge of quality assurance terminology, software, methods, and tools.
Previous experience with Laboratory Information Management Systems is preferred.
Proficient in QMS software (i.e. MediaLab, TrackWise, MasterControl or similar)
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
Compensation (DOE):
$180,000 - $210,000 annual salary
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