Manager, Regulatory Affairs (Medtech)

TL;DR

Manager, Regulatory Affairs (Medtech): Developing and executing regulatory strategies for wearable medical devices and AI-based Software as a Medical Device (SaMD) with an accent on FDA submissions and EU MDR compliance. Focus on leading 510(k) filings, managing regulatory associates, and ensuring compliance for AI and cybersecurity frameworks.

Location: Remote (US)

Salary: $127,000 - $165,000

Company

hirify.global is a leading digital healthcare company creating trusted solutions that detect, predict, and prevent cardiac disease using wearable biosensors and cloud-based data analytics.

What you will do

• Develop and execute regulatory strategies for new and modified medical devices in line with business objectives.
• Manage regulatory associates, overseeing work planning, guidance, execution, and talent development.
• Lead FDA submissions (510(k) or pre-submissions) for wearable devices and AI Software as a Medical Device (SaMD) products.
• Lead EU MDR Technical Documentation and other international submissions for both wearables and SaMD.
• Act as the lead regulatory expert in AI, SaMD, and Cybersecurity, establishing compliance processes.
• Review and approve advertising, promotional materials, and product design changes to maintain regulatory compliance.

Requirements

• BA or BS degree in engineering, life sciences, or a related field.
• 8-10 years of US and/or EU regulatory affairs experience (6 years minimum with a Master's degree).
• Proven experience with Software as a Medical Device (SaMD) and new product development.
• Demonstrated experience authoring 510(k)s and managing FDA reviews to gain clearance.
• Competency in 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, and HIPAA.
• Must be based in the United States.

Nice to have

• Experience with wearable medical devices.
• Familiarity with global medical device regulations in LATAM, Asia Pac, and EMEA.
• Audit support experience.

Culture & Benefits

• Comprehensive health benefits including medical, dental, and vision insurance.
• 401K plan with company match.
• Employee Stock Purchase Plan (ESPP).
• Paid holidays and paid time off.
• Inclusive work environment with a focus on patient-first innovation.