Manager, Regulatory Submissions (AI/Medical Devices)

Location: Remote, with the stated salary range applicable to Illinois and varying for California, Colorado, and New York.

Salary: $110,000–$150,000 per year, depending on location, qualifications, and experience.

Company

hirify.global develops a precision medicine platform that uses real-world evidence and AI to support clinical decision-making and personalized treatment.

What you will do

• Develop and lead global regulatory strategies aligned with business and commercial objectives.
• Lead submissions and correspondence with regulatory authorities, including FDA 510(k), PMA, De Novo, IDE, CE marking, and UKCA registrations.
• Establish scalable processes for addressing multiple regulatory frameworks and execute premarket and postmarket project plans.
• Assess medical device and IVD changes, including change controls that may require reporting or new submissions.
• Guide scientists, engineers, clinicians, quality professionals, legal specialists, and other subject-matter experts in preparing regulatory documentation.
• Report regulatory progress to executive leadership and operationalize strategic direction.

Requirements

• Oncology IVD, IUO, and CDx experience.
• At least 5 years of regulatory affairs experience related to medical devices.
• Experience with complex devices involving genomics, NGS, software, AI, clinical decision support, or oncology.
• Knowledge of PMA, De Novo, 510(k), IDE, CE marking, UKCA, IVDR, MDR, CAP/CLIA, 21 CFR 820/ISO 13485, and 21 CFR 812 requirements.
• Experience with software validation, risk management, medical device cybersecurity, machine learning validation, lifecycle management, and performance testing.
• Scientific background with knowledge of engineering and biology, strong project management skills, communication abilities, attention to detail, and experience interacting with regulators.

Nice to have

• PhD.
• Experience working in a startup-like environment.

Culture & Benefits

• Remote work arrangement.
• Cross-functional collaboration across quality, clinical, medical, bioinformatics, laboratory, engineering, and business teams.
• Work on regulated healthcare products supporting precision medicine.
• Benefits may include incentive compensation, restricted stock units, medical benefits, and other employee benefits depending on the position.