Manager, Regulatory Affairs (Medtech)

TL;DR

Manager, Regulatory Affairs (Medtech): Developing and executing regulatory strategies for new and modified medical devices with an accent on FDA submissions, SaMD, and AI-driven cardiac health solutions. Focus on leading regulatory compliance for product life cycles, managing international filings, and ensuring adherence to global medical device standards.

Location: Remote - US

Salary: $127,000 - $165,000

Company

hirify.global is a leading digital healthcare company that combines wearable biosensors and proprietary algorithms to provide actionable cardiac health insights.

What you will do

• Develop and execute regulatory strategies for new and modified medical devices.
• Lead FDA submissions including 510(k) and pre-submissions for wearable devices and AI-based SaMD products.
• Manage regulatory associates, providing guidance, work planning, and talent development.
• Oversee EU MDR Technical Documentation and international regulatory filings.
• Serve as the regulatory SME for AI, SaMD, and Cybersecurity compliance.
• Review and approve advertising materials and product design changes to ensure regulatory compliance.

Requirements

• Must be based in the US
• Bachelor’s degree in engineering, life sciences, or related field.
• 8-10 years of regulatory affairs experience (6 years with a Master’s degree).
• Proven experience with 510(k) submissions and FDA review management.
• Demonstrated competency in 21 CFR 820, EU MDD/MDR, ISO 13485, and IEC 62304.
• Experience with Software as a Medical Device (SaMD) and new product development.

Nice to have

• Experience with wearable medical devices.
• Familiarity with global regulations in LATAM, Asia Pac, and EMEA.
• Previous experience supporting external and internal audits.

Culture & Benefits

• Competitive salary package with 401K company match.
• Comprehensive medical, dental, and vision insurance.
• Employee Stock Purchase Plan.
• Paid holidays and generous paid time off.
• Inclusive work environment with organizational and cultural committee events.