Senior Regulatory Affairs Specialist — Medical Devices

Job overview

The Senior Regulatory Affairs Specialist role is hybrid in West Jordan, UT, or San Mateo, CA. Pay is $140,000–$160,000 per year. Route 92 Medical develops neurovascular medical devices with a mission to improve outcomes for patients undergoing neurovascular intervention. The specialist manages international regulatory submissions, registrations, and product lifecycle activities to support market authorization and continued access. The role assesses regulatory impacts of product and quality-system changes, advises cross-functional teams, and supports audits and inspections across international markets.

What you'll do

• Prepare and manage international medical-device submissions, registrations, amendments, renewals, and lifecycle activities, primarily for the UK, Japan, and Latin America
• support EU, Canada, and Australia activities as assigned
• assess regulatory impacts of product and quality-system changes
• advise cross-functional teams
• review labeling and controlled documentation
• track commitments and renewals
• improve regulatory processes
• support audits and inspections
• travel approximately 5%.

What we're looking for

Skills & competencies

senior regulatory affairs specialist

medical devices

international regulatory affairs

regulatory submissions

uk

japan

latin america

west jordan ut

san mateo ca

hybrid

$140k–$160k/year

5% travel

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, life insurance, FSA, HSA, short- and long-term disability, critical illness and accident insurance
• corporate bonus program
• paid time off
• 16 paid holidays
• 12 weeks of paid parental leave after 90 days
• monthly cell phone stipend.

Why this role

Hybrid work in West Jordan, UT, or San Mateo, CA; primary markets include the UK, Japan, and Latin America; approximately 5% domestic and international travel.

About the employer

Route 92 Medical Inc is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.