Regulatory Affairs Manager

Route 92 Medical Inc • San Mateo, CA

14h • Hybrid

About The Position

This Regulatory Affairs Manager will work onsite in our San Mateo office 2-3 days a week. This position will support Route 92 Medical's efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements (13485:2016, MDSAP, EU MDR 2017/745) as well as ensuring products meet all applicable internal and external requirements and specifications.

Requirements

• Minimum of 5 years work experience in Regulatory Affairs specifically with Medical Device
• At least 2 years in a Management or Leadership role with indirect or direct reports
• Bachelors of Science Degree required

Nice To Haves

• Adaptable to fast-paced environment
• Attention to detail and focus on identification of potential issues and continuous improvement
• Experience with eQMS or RAMs system (e.g.Grand Avenue, DOT Compliance)

Responsibilities

• Owns products/regions; manages day‑to‑day regulatory activities and small team.
• Translates regulatory strategy into project plans for assigned products and markets.
• Leads preparation and review of submissions and responses to authorities.
• Monitors changes for assigned markets and updates procedures and documentation.
• Ensures regulatory processes are followed; leads regulatory CAPAs and supports audits.
• Represents RA in project teams; provides guidance to R&D, Quality, and Marketing.
• Manages individual contributors; handles workload, coaching, and performance reviews.
• Manages project‑level budgets (consultants, fees, testing) within assigned scope.
• Interfaces with notified bodies, health authorities, and distributors on specific submissions and issues.
• Recommends and implements decisions within established strategy and policies.
• Other regulatory tasks as requested by management.

Benefits

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including but not limited to; Medical, Dental, Vision, Life Insurance, FSA, HSA, Short- & Long-Term Disability, Critical Illness Insurance, and Accident Insurance
• Competitive base pay plus corporate bonus program and equity
• Paid vacation and 16 paid holidays, including a company-wide week off in July
• 12 weeks paid parental leave (eligible after 90 days of employment)
• Monthly cell phone stipend

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level