Senior Regulatory Affairs Specialist (Medical Devices)

Location: Remote - US; willingness to travel up to 10% when required.

Salary: $99,000–$129,000 per year

Company

hirify.global is a digital healthcare company developing wearable biosensors, cloud-based analytics, and proprietary algorithms for cardiac health.

What you will do

• Develop global, regional, and multi-country regulatory strategies for new and modified medical devices.
• Prepare domestic and international product filings and registrations within established timelines.
• Guide cross-functional teams from submission preparation through regulatory review and approval.
• Interact with regulatory authorities and coordinate product changes, notifications, and registration maintenance.
• Review design changes, promotional materials, labeling, and quality-system procedures for regulatory compliance.
• Monitor changing regulations and support product recalls and international communications.

Requirements

• Bachelor’s degree required.
• At least 3 years of regulatory affairs experience in the medical device industry.
• Experience with global medical device regulations, including 21 CFR 820, MDD/CMDR, EU MDR, and UKCA.
• Understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, HIPAA, and other international standards and regulations.
• Product development or sustaining/lifecycle management experience.
• Strong written and verbal communication, problem-solving, and organizational skills.

Nice to have

• Master’s or another advanced degree in a related field.
• Experience with SaMD/MDSW, wearable, or OTC medical devices.
• Project management skills.

Culture & Benefits

• Collaborative, fast-paced environment focused on patient care and healthcare innovation.
• Medical, dental, and vision insurance beginning on the first day.
• Paid holidays, PTO, and paid parental leave.
• 401(k) with company match and Employee Stock Purchase Plan.
• Pet insurance discount and cultural committee and charity events.