Regulatory & Quality Scientist – Cancer Diagnostics

OncoFirm™ Diagnostics Corporation
Department: Regulatory Affairs & Quality Assurance
Employment Type: Full-Time
Location: Open / Flexible
Focus: IVD Diagnostics | FDA Regulatory Affairs | Quality Systems | Cancer Diagnostics

About OncoFirm™ Diagnostics

OncoFirm™ Diagnostics Corporation is developing next-generation diagnostic technologies designed to support earlier and more accessible detection of cancer-associated biomarkers.

Our platform combines fluorescent lateral flow assays, electronic reader technology, quantitative signal analysis, and AI-assisted interpretation to support the development of portable, connected point-of-care diagnostic systems.

As our diagnostic programs advance, we are seeking regulatory and quality professionals who want to help establish the systems, documentation, and regulatory strategies necessary to move innovative diagnostic technologies from research and development through validation, clinical evaluation, manufacturing, regulatory submission, and commercialization.

Position Summary

OncoFirm is seeking a detail-oriented and scientifically knowledgeable Regulatory & Quality Scientist to support the development of our cancer diagnostic and in vitro diagnostic (IVD) programs.

This position operates at the intersection of science, product development, regulatory affairs, and quality management, helping ensure that OncoFirm’s diagnostic technologies are developed in accordance with applicable U.S. and international regulatory and quality requirements.

The successful candidate will collaborate with assay-development, engineering, software, clinical, manufacturing, and management teams while contributing to regulatory strategy, quality-system development, design and development controls, risk management, verification and validation, and regulatory documentation.

We welcome experienced regulatory and quality professionals as well as highly qualified candidates with scientific or engineering backgrounds and relevant experience in IVDs, medical devices, diagnostics, or regulated product development.

Key Responsibilities

• Support development and implementation of regulatory strategies for OncoFirm diagnostic products.
• Assist with preparation and coordination of FDA premarket submissions, including 510(k), De Novo, PMA, or other applicable regulatory pathways.
• Support FDA pre-submission interactions and regulatory documentation as appropriate.
• Support CLIA waiver planning and documentation when applicable to specific diagnostic products.
• Support European regulatory strategy in accordance with the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), Regulation (EU) 2017/746, including applicable CE-marking requirements.
• Support implementation and maintenance of OncoFirm’s Quality Management System in accordance with the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485:2016, and other applicable requirements.
• Develop and maintain quality and regulatory documentation throughout the product-development lifecycle.
• Support design and development planning, requirements, reviews, verification, validation, transfer, and change-control activities.
• Assist in maintaining design and development documentation, device specifications, manufacturing documentation, technical documentation, and regulatory records.
• Support analytical and clinical performance evaluation planning and documentation.
• Participate in product and process risk-management activities consistent with applicable standards, including ISO 14971.
• Develop and maintain risk-management documentation, including hazard analyses and Failure Mode and Effects Analyses (FMEA).
• Collaborate with R&D and engineering teams to incorporate regulatory and quality requirements early in product development.
• Support document control, change control, CAPA, nonconformance, supplier quality, training, and records-management processes.
• Participate in internal quality audits and support external audits and regulatory inspections.
• Support supplier qualification and oversight activities.
• Assist with product labeling, Instructions for Use (IFU), intended-use statements, indications, warnings, and claims-support documentation.
• Support verification and validation activities for assays, instrumentation, software, and connected diagnostic systems.
• Monitor evolving U.S. and international regulatory requirements affecting IVDs and medical devices.
• Support post-market surveillance, complaint handling, corrective and preventive actions, vigilance, and regulatory reporting processes as products progress toward commercialization.
• Coordinate with external regulatory consultants, testing laboratories, clinical partners, manufacturers, suppliers, and development organizations.

Regulatory & Quality Areas of Interest

Candidates with knowledge or experience in one or more of the following areas are especially encouraged to apply:

• FDA Quality Management System Regulation (QMSR)
• 21 CFR Part 820
• ISO 13485:2016
• ISO 14971 Risk Management
• EU IVDR — Regulation (EU) 2017/746
• FDA 510(k) submissions
• De Novo classification requests
• Premarket Approval (PMA)
• FDA Pre-Submission process
• CLIA waiver
• Design and development controls
• Quality Management Systems
• Verification and validation
• CAPA
• Nonconformance management
• Change control
• Supplier quality
• Internal and external audits
• Risk management and FMEA
• Technical documentation
• Product labeling and IFUs
• Analytical performance studies
• Clinical performance studies
• Lateral flow assays
• Immunoassays
• Point-of-care diagnostics
• Software-enabled medical devices
• Connected diagnostic systems

Qualifications

Education

Bachelor’s or Master’s degree in one of the following or a related discipline:

• Regulatory Science
• Biology
• Molecular Biology
• Biochemistry
• Chemistry
• Biomedical Engineering
• Biotechnology
• Bioengineering
• Quality Assurance
• Medical Device Sciences
• Life Sciences

Advanced degrees and relevant professional certifications are welcomed but not required.

Preferred Experience

• Approximately 3+ years of experience in regulatory affairs, quality assurance, IVDs, medical devices, diagnostics, biotechnology, or another regulated life-sciences environment.
• Working knowledge of FDA QMSR, 21 CFR Part 820, and ISO 13485:2016.
• Understanding of medical-device and IVD design and development requirements.
• Experience preparing, reviewing, or supporting regulatory submissions is highly desirable.
• Knowledge of EU IVDR (EU) 2017/746 and international IVD regulatory requirements is beneficial.
• Experience with risk management under ISO 14971.
• Experience with CAPA, nonconformance management, document control, change control, audits, supplier quality, or verification and validation.
• Strong scientific, regulatory, and technical writing skills.
• Ability to interpret regulatory requirements and translate them into practical product-development and quality-system activities.
• Strong organizational skills and exceptional attention to detail.
• Ability to work effectively across scientific, engineering, clinical, manufacturing, quality, regulatory, and business teams.

Experience with lateral flow diagnostics, fluorescent immunoassays, cancer diagnostics, point-of-care devices, electronic diagnostic readers, software-enabled medical devices, or AI-assisted diagnostic systems is especially valuable.

What You’ll Help Build

OncoFirm is developing an integrated diagnostic platform combining:

Cancer Biomarkers → Fluorescent Lateral Flow Assays → Electronic Reader → Quantitative Signal Analysis → AI-Assisted Interpretation → Connected Diagnostic Data

The Regulatory & Quality Scientist will help establish and maintain the regulatory and quality framework supporting this platform as it progresses through:

Research & Development → Design & Development → Analytical Validation → Clinical Evaluation → Manufacturing → Regulatory Submission → Commercialization

This position provides the opportunity to participate across:

Regulatory Strategy • Quality Management Systems • Design & Development Controls • Risk Management • Verification & Validation • Clinical Development • Manufacturing • Software • AI-Assisted Diagnostics • Regulatory Submissions • Post-Market Quality

Compensation

Base Salary Range: $85,000–$135,000 annually

Final compensation will be based on education, relevant experience, regulatory and quality expertise, and demonstrated experience with IVDs, medical devices, or diagnostic-product development.

Depending on position level and company program structure, additional compensation may include performance-based incentives and/or equity participation.

Why Join OncoFirm?

This position provides an opportunity to help build the regulatory and quality foundation of an emerging diagnostic technology company.

Rather than supporting only an established product, the successful candidate may participate throughout the development lifecycle—from early-stage R&D and design controls through analytical and clinical validation, manufacturing readiness, regulatory submissions, and commercialization.

We value:

Scientific Integrity • Quality • Regulatory Excellence • Collaboration • Innovation • Attention to Detail • Patient Impact

About OncoFirm™ Diagnostics Corporation

OncoFirm™ Diagnostics Corporation is a biotechnology and diagnostic-development company advancing technologies for rapid and accessible biomarker detection.

Our research and development programs focus on integrating fluorescent lateral flow assays, electronic reader technology, quantitative signal analysis, connectivity, and AI-assisted interpretation into next-generation diagnostic systems.

Website: www.oncofirm.com

OncoFirm™ Diagnostics Corporation is an equal opportunity employer. Employment decisions are based on qualifications, experience, skills, and the requirements of the position.