Senior Regulatory Affairs Specialist

Route 92 Medical; San Mateo (CA); Hybrid; USD 140,000 - 160,000; Full time

Benefits offered by this job

Healthcare benefits day one

Paid time off & holidays

Parental leave

Cell phone stipend

Job summary

Route 92 Medical is seeking a Senior Regulatory Affairs Specialist to lead international submissions and regulatory lifecycle activities for UK, LATAM, and Japan from our San Mateo option or West Jordan, UT in a hybrid working environment.

The role requires a minimum of 5 years in medical device regulatory affairs, plus strong writing and communication skills to collaborate with cross-functional teams and regulatory authorities.

Qualifications

• 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.
• Hands-on experience with medical device submissions or registrations in the United Kingdom.
• Hands-on experience with medical device registrations in Latin America, including Brazil and at least one additional LATAM market (e.g., Mexico, Colombia, Argentina).
• Experience supporting or managing medical device regulatory submissions and market authorization activities in Japan.
• Working knowledge of ISO 13485, MDSAP, and applicable international medical device regulatory requirements.
• EU MDR, Health Canada, and/or Australian TGA experience 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.

Skills

Regulatory affairs

Medical device

Technical writing

Communication

Attention to detail

Education

Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, or another relevant scientific or technical discipline

Advanced degree or RAC is a plus

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Regulatory Affairs Specialist

FullTime San Mateo, CA, US

Salary Range: $140,000.00 To $160,000.00 Annually

About Route 92 Medical

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.

Purpose of Job

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.

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.

Skills for Success

• 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.

Required Education

• Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, or another relevant scientific or technical discipline.
• Advanced degree or RAC is a plus.

Required Experience

• 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.
• Experience with EU MDR, Health Canada, and/or Australian TGA requirements is preferred.

Benefits & Perks

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term disability, Critical Illness Insurance, and Accident Insurance.
• 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

The actual base pay is dependent on several factors, including, but not limited to, work experience, market data, skills, geographic location, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity.