Regulatory Affairs Advisor (FDA Pharma & IVDR)

Location: Remote USA

Salary: $146,100–$182,600 USD annually

Company

hirify.global develops non-invasive cell-free DNA and liquid biopsy testing solutions for oncology, women’s health, and organ health.

What you will do

• Develop and execute regulatory strategies for FDA Pharma, IVDR, IVD, and complex global registration programs.
• Prepare and coordinate regulatory submissions, including IVDR technical documentation, classification requests, pre-submissions, 510(k) notifications, investigational device exemptions, and NYS Department of Health submissions.
• Represent Regulatory Affairs on cross-functional teams and communicate with customers, regulators, and internal technical and scientific stakeholders.
• Review product changes, advertising, promotion, labeling, performance claims, and supporting data for regulatory compliance and submission impact.
• Lead regulatory change, compliance, process improvement, and data-driven solution initiatives.
• Mentor regulatory associates and deliver regulatory training across internal teams.

Requirements

• Bachelor’s degree in life sciences, engineering, medical technology, regulatory science, or an equivalent field.
• 8+ years of direct regulatory experience in medical devices, laboratory-developed tests, or pharma.
• Working knowledge of U.S. and EU medical device, IVD/IVDR, FDA Pharma, and/or laboratory-developed test requirements.
• Experience with FDA Pharma and IVDR submissions is highly preferred; IVD, companion diagnostics, and PMA experience are advantageous.
• Strong written and verbal communication, scientific judgment, project management, and continuous improvement skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.

Nice to have

• Advanced degree in life sciences or an MBA.
• Regulatory Affairs Certification (RAC).
• Experience in organ health or women’s health diagnostics.

Culture & Benefits

• Medical, dental, vision, life, and disability insurance for eligible employees and dependents.
• Free testing for employees and immediate family members, plus fertility care benefits.
• Pregnancy and baby bonding leave, 401(k), commuter benefits, and an employee referral program.
• Collaborative environment with statisticians, geneticists, physicians, laboratory scientists, software engineers, and business professionals.