Regulatory & Quality Scientist – Cancer Diagnostics
Job Title: Regulatory & Quality Scientist – Cancer Diagnostics
Location: open
Job Type: Full-Time
Department: Regulatory Affairs & Quality Assurance
Reports To: VP of Regulatory Affairs / Head of Compliance
About OncoFirm Diagnostics
At OncoFirm Diagnostics, our mission is fueled by purpose—every member of our team has been personally touched by cancer. We are building innovative rapid diagnostic tests to detect cancer at its earliest stages, when lives can still be saved. As we grow, we’re looking for compassionate, detail-driven professionals who are just as committed to making a difference as we are.
Position Summary
We are seeking an experienced Regulatory & Quality Scientist to join our team and help guide the development, validation, and approval of our rapid cancer diagnostic tests. This role bridges science and compliance, ensuring our products meet rigorous quality standards and gain timely regulatory approval in global markets.
Key Responsibilities
- Lead regulatory strategy and submission preparation for FDA (510(k), EUA, CLIA waiver), CE-IVD, and other global regulatory bodies
- Maintain quality documentation in compliance with ISO 13485, FDA QSR, and GMP guidelines
- Support the development of Design History Files (DHF), Device Master Records (DMR), and Technical Files
- Collaborate with R&D and Manufacturing to ensure design controls and validation are fully aligned with quality standards
- Conduct internal audits and coordinate with external auditors and regulatory bodies
- Track and interpret global regulatory requirements for IVDs and implement changes as needed
- Assist with risk management activities, including hazard analysis and failure mode effect analysis (FMEA)
- Support product labeling, instructions for use (IFU), and claims substantiation documentation
- Participate in post-market surveillance activities, including complaint handling and CAPA investigations
Qualifications
- Bachelor’s or Master’s degree in Biology, Chemistry, Biomedical Engineering, Regulatory Science, or related field
- 3–7 years of experience in regulatory affairs and/or quality assurance in the IVD, medical device, or diagnostics industry
- Strong knowledge of FDA, ISO 13485, CE-IVD, and other international regulatory standards
- Experience with lateral flow or point-of-care diagnostics is a plus
- Excellent written and verbal communication skills for regulatory submissions and cross-functional collaboration
- Detail-oriented, organized, and capable of working independently in a fast-paced startup environment
💼 Salary Range
| Experience Level | Base Salary Range (USD) | Total Comp (with bonuses/equity) |
|---|---|---|
| Mid-Level (3–5 years) | $85,000 – $110,000 | $90,000 – $125,000 |
| Senior-Level (6–10+ years) | $110,000 – $135,000 | $120,000 – $150,000+ |
Note: Compensation may include equity or performance-based bonuses depending on experience and company stage.
Why Join OncoFirm?
- Be part of a mission-driven company changing lives through early cancer detection
- Work with a passionate, interdisciplinary team committed to innovation and patient impact
- Competitive salary, equity participation, and a full benefits package
- A fast-paced, startup environment where your work directly influences patient outcomes
OncoFirm Diagnostics is a performance-based employer. We celebrate talent by hiring only the best and are committed to creating a stress-free environment for all employees.
