Director, Regulatory Affairs & Quality Assurance

CellMax Life is hiring a Director of Regulatory Affairs & Quality Assurance to own the regulatory path and quality system for its cancer screening blood tests. Title Director, Regulatory Affairs & Quality Assurance Company CellMax Life, Inc. Location Sunnyvale, CA (onsite) Employment type Full-time, exempt About CellMax Life CellMax Life is a Sunnyvale-based molecular diagnostics company developing non-invasive blood tests for early cancer detection. The company's lead product, FirstSight™, is a blood test for colorectal cancer and pre-cancerous advanced adenomas. Position Summary The Director of RA/QA leads CellMax Life's regulatory strategy and quality management system as FirstSight moves from clinical validation toward FDA marketing authorization and commercial launch. This is a hands-on leadership role in a growing company: you will set strategy, write and review submissions, build and run the QMS, and be the company's primary contact with FDA and other regulators. You will partner closely with department team-leads, and build the RA/QA function as the company scales. Key Responsibilities Regulatory strategy and submissions Define and execute the U.S. regulatory pathway for FirstSight and future products, including the premarket submission (e.g., PMA) and any supplements and lead FDA interactions including Q-Submissions. Own regulatory compliance for clinical studies: IDE and significant-risk determinations (21 CFR 812), informed consent (Part 50) and IRB requirements (Part 56). Author and review submission content: analytical and clinical validation summaries, software and algorithm documentation, labeling and risk analysis. Assess regulatory requirements for international markets as the business expands. Monitor regulatory changes affecting IVDs and advise leadership on their impact. Quality management system Build, maintain and continuously improve a QMS compliant with FDA's QMSR (21 CFR 820, incorporating ISO 13485:2016) and ISO 14971 risk management. Oversee design controls, document and record control, change control, supplier qualification, training, internal audits and management review. Run the CAPA, nonconformance and complaint-handling processes, including trending and effectiveness checks. Prepare the company for FDA inspections, including pre-approval inspections, and lead the inspection and response. Serve as the Management Representative for the company. Post-market surveillance Establish and own Medical Device Reporting (21 CFR 803), corrections and removals (21 CFR 806) and post-approval study obligations. Ensure timely, accurate adverse event and vigilance reporting in every market where products are sold. Leadership Build, hire and develop the RA/QA team and set its annual goals and budget. Promote a culture of quality and compliance across the company, and train staff on their regulatory responsibilities. Report quality and regulatory status, risks and metrics to the executive team and board. Qualifications Required Bachelor's degree in a life science, engineering or related field; advanced degree (MS, PhD, PharmD) a plus. 12+ years of RA and/or QA experience in IVD or medical devices, including 5+ years leading people. Hands-on leadership of at least one successful FDA premarket submission (PMA, De Novo or 510(k)); PMA experience strongly preferred. Demonstrated experience building or remediating a QMS to 21 CFR 820 / ISO 13485 and ISO 14971. Direct experience hosting FDA inspections and managing 483 responses. Working knowledge of 21 CFR 803, 806, 809 and 812, and of design controls for IVDs. Clear written and verbal communication, including with FDA reviewers and senior leadership. Preferred Experience with oncology, molecular, NGS or liquid biopsy diagnostics, especially screening tests. Experience with the Breakthrough Devices Program and Q-Submission process. Familiarity with software as a medical device, algorithm validation and cybersecurity requirements. RAC certification; ASQ CQA or CMQ/OE. Experience in an early-stage or venture-backed company. Compensation and Benefits The base salary range for this role in Sunnyvale, CA is $[MIN] – $[MAX] per year. Actual pay depends on experience, skills and qualifications. Equity An annual bonus Medical coverage Dental coverage Vision coverage 401(k) plan Paid time off Equal Opportunity CellMax Life is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected characteristic. We consider qualified applicants with arrest or conviction records in accordance with applicable law. #J-18808-Ljbffr CellMax Life