Senior Regulatory Affairs Specialist

Route 92 Medical Inc • San Mateo, CA

1d • $140,000 - $160,000 • Hybrid

About The Position

Route 92 Medical is seeking a Senior Regulatory Affairs Specialist to execute international regulatory activities for their neurovascular intervention products. The primary focus will be on regulatory submissions, registrations, and lifecycle management in the United Kingdom, Latin America, and Japan. This role involves independently preparing and maintaining international regulatory submissions, conducting regulatory assessments of product and Quality System changes, and collaborating with regulatory authorities, in-country representatives, distributors, and other regulatory partners to secure and maintain market authorization. The position will have significant responsibility for the UK, Japan, and Latin American markets (including Brazil, Mexico, Colombia, Argentina, and other LATAM countries), with additional support for the European Union, Canada, Australia, and other international markets as needed. This role will be based onsite in San Mateo, CA or West Jordan, UT, operating in a hybrid work environment.

Requirements

• Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, or another relevant scientific or technical discipline.
• Minimum 5 years of progressively responsible regulatory affairs experience in the medical device industry.
• Demonstrated ability to independently manage regulatory submissions, registrations, amendments, and renewals across multiple countries and regulatory frameworks simultaneously — including identifying country-specific requirements, preparing documentation, managing timelines, responding to regulatory questions, and maintaining existing market authorizations.
• Demonstrated hands-on experience with medical device submissions or registrations in the United Kingdom.
• Demonstrated hands-on experience with medical device registrations in Latin America, including Brazil and at least one additional LATAM market (e.g., Mexico, Colombia, Argentina).
• Demonstrated hands-on experience supporting or managing medical device regulatory submissions and market authorization activities in Japan.
• Experience working directly with international regulatory authorities, in-country representatives, regulatory consultants, importers, and distributors.
• Demonstrated experience conducting regulatory change assessments and determining regulatory impact of product, design, manufacturing, supplier, labeling, software, and Quality System changes.
• Working knowledge of ISO 13485, MDSAP, and applicable international medical device regulatory requirements.
• Strong knowledge of international medical device regulatory principles and market authorization requirements.
• Strong technical writing and regulatory submission preparation skills.
• Strong written and verbal communication skills, with the ability to convey regulatory requirements and recommendations to both technical and non-technical stakeholders.
• Strong attention to detail and ability to maintain accurate, inspection-ready regulatory documentation.

Nice To Haves

• Advanced degree or RAC is a plus.
• Experience with EU MDR, Health Canada, and/or Australian TGA requirements is preferred.

Responsibilities

• Prepare, coordinate, and manage international medical device submissions, registrations, amendments, renewals, and other market authorization activities, with primary responsibility for the United Kingdom, Japan, and Latin America.
• Manage regulatory registration and lifecycle activities across Latin America, including Brazil, Mexico, Colombia, Argentina, and additional LATAM markets, as applicable.
• Prepare and coordinate regulatory documentation and submissions for Japan, working with applicable in-country regulatory partners and internal cross-functional teams to support initial market authorization and ongoing lifecycle activities.
• Manage UK medical device regulatory activities, including product registration, maintenance of applicable regulatory documentation, and coordination with the UK Responsible Person and other regulatory partners, as applicable.
• Prepare regulatory submissions, registrations, and lifecycle activities for the European Union, Canada, and Australia, as assigned.
• Conduct and document regulatory change assessments for product, design, manufacturing, supplier, material, labeling, sterilization, and Quality System changes to determine applicable regulatory requirements and impact to existing clearances, approvals, registrations, and market authorizations.
• Determine whether proposed changes require regulatory notification, submission, approval, registration updates, or other regulatory action prior to implementation across applicable markets.
• Provide regulatory guidance to cross-functional teams regarding international regulatory requirements and the potential regulatory impact of proposed changes.
• Review product labeling, Instructions for Use, and other controlled documentation for compliance with applicable international regulatory requirements.
• Track international registration commitments, renewals, expirations, regulatory changes, and other market-specific requirements to ensure continued market access.
• Identify opportunities to improve regulatory processes, procedures, templates, tracking tools, and systems and implement improvements as appropriate.
• Support internal, supplier, Notified Body, MDSAP, and regulatory authority audits and inspections.
• Perform other regulatory responsibilities as assigned by the Regulatory Affairs Manager.
• Travel approximately 5%, including potential domestic and international travel as required.

Benefits

• Comprehensive healthcare benefits are effective day one!
• Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term disability, Critical Illness Insurance, and Accident Insurance.
• Competitive base pay plus corporate bonus program
• Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July
• 12 weeks of paid parental leave for employees after 90 days of employment
• Monthly cell phone stipend

What This Job Offers

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