Senior Regulatory Affairs Specialist (MedTech)

Location: Remote, US; expected travel.

Salary: $138,146.76–$154,399.32 for Tier 3 or $155,415.11–$173,699.24 for Tier 2 annually.

Company

hirify.global develops AI-powered digital stethoscopes, ECG hardware, and FDA-cleared digital health products for detecting cardiac and pulmonary disease.

What you will do

• Lead QMS architecture and regulatory remediation, aligning global procedures into streamlined workflows.
• Revise and consolidate SOPs covering DHF, design and development files, post-market surveillance, labeling, UDI, EUDAMED, and regulatory strategy.
• Drive regulatory documentation cleanup and maintain the global submissions and deficiencies database.
• Develop and execute registration strategies across the EU, UK, Canada, APAC, and LATAM.
• Manage Notified Body and EU Authorized Representative interactions, including technical file reviews, change notifications, and DoC/CE updates.
• Represent Regulatory Affairs on hardware and AI/software release teams and standardize claims, IFU, advertising, and promotional review processes.

Requirements

• Bachelor’s or advanced degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical discipline.
• 5–8+ years of progressive regulatory affairs experience in medical devices, digital health, and/or SaMD.
• Strong knowledge of FDA 21 CFR 820/QMSR, EU MDR 2017/745, ISO 13485, and global regulatory submissions.
• Direct experience preparing or submitting 510(k)s, Q-Subs, De Novo submissions, and Technical Files, plus managing Notified Body reviews.
• Experience leading QMS remediation programs and global market entries.
• Strong communication, organizational, and problem-solving skills; ability to perform the role with or without reasonable accommodation.

Nice to have

• Regulatory Affairs Certification (RAC).
• Experience in a startup or high-growth environment.

Culture & Benefits

• Remote work with expected travel.
• Paid time off and parental leave.
• Medical, dental, vision, disability, and life insurance.
• One Medical membership and 401(k) matching.
• Stock incentive plan and learning and development stipend.