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.
- 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
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.
