Senior Regulatory Affairs Specialist

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Full Time San Mateo, CA, US

Salary Range: $ To $ Annually

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes.

Route 92 Medical is looking for dynamic, innovative people who are inspired by our mission to improve outcomes for patients undergoing neurovascular intervention.

We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others. Teamwork matters here. We are committed to collaboration and finding innovative solutions that advance neurovascular intervention, establishing Route 92 Medical as one of the premier companies in the field.

The Senior Regulatory Affairs Specialist is responsible for executing international regulatory activities for Route 92 Medical products, with primary responsibility for regulatory submissions, registrations, and lifecycle activities in the United Kingdon, Latin America, and Japan.

This role will independently prepare and maintain international regulatory submissions and registrations, conduct regulatory assessments of product and Quality System changes, and work with regulatory authorities, in-country representatives, distributors, and other regulatory partners to obtain and maintain market authorization.

The position will have significant responsibility for 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 position will be onsite in San Mateo, CA or West Jordan, UT in a hybrid working environment.

• 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…