Regulatory Affairs & Quality Lead (Oncology)

Location: North Brunswick, New Jersey, United States; on-site

Salary: $130,000–$160,000 per year, commensurate with experience

Company

hirify.global develops cancer diagnostics by integrating pathology, advanced imaging, artificial intelligence, and complementary biological data.

What you will do

• Develop and execute regulatory strategies and roadmaps for clinical validation, diagnostic development, regulatory readiness, and commercialization.
• Assess regulatory pathways for laboratory-developed tests, in vitro diagnostics, and companion diagnostics.
• Lead submission planning and agency interactions while monitoring FDA and other applicable requirements.
• Own and continuously improve the Quality Management System, including SOP governance, document control, training, CAPA, and change control.
• Coordinate internal audits, support external inspections, and strengthen readiness for FDA, CLIA, CAP, and future quality requirements.
• Partner with research, clinical, laboratory, manufacturing, AI, software engineering, and executive teams to implement practical regulatory and quality processes.

Requirements

• Bachelor’s degree in life sciences, biomedical engineering, regulatory affairs, quality, or a related scientific or technical discipline.
• 5–8+ years of progressive Regulatory Affairs experience in biotechnology, diagnostics, medical devices, pharmaceuticals, or another regulated life sciences environment.
• Experience with regulatory submissions, agency interactions, regulatory strategies, FDA regulations, and applicable requirements.
• Hands-on experience with Quality Management Systems, SOP governance, document control, CAPA, change control, training, and audit readiness.
• Strong project management, communication, judgment, and cross-functional collaboration skills.
• Ability to work in a hands-on, fast-paced, growth-stage biotechnology environment.

Nice to have

• Experience with molecular diagnostics, IVDs, companion diagnostics, pathology, digital pathology, or AI-enabled healthcare technologies.
• Familiarity with CLIA, CAP, ISO 13485, and laboratory quality systems.
• Experience building Regulatory Affairs and Quality capabilities in a startup or growth-stage organization.
• RAC, CQA, or CMQ/OE certification.

Culture & Benefits

• Medical, dental, vision, and other ancillary benefits.
• 401(k) plan and professional development opportunities.
• Meaningful equity opportunity and compensation aligned with seniority and experience.
• High ownership and visibility with scientific and executive leadership.
• Collaborative, multidisciplinary work focused on early cancer detection.