Job details
International Regulatory Affairs Specialist
San Jose, CA
Join a team that plays a key role in bringing life‑changing medical technologies to patients around the world. In this role, you will ensure global product registrations move efficiently and compliantly through diverse regulatory pathways. This is a meaningful opportunity to drive operational excellence, collaborate across global teams, and directly influence our ability to deliver safe, effective products to patients internationally.
Work Flexibility:
Hybrid - must reside within a commutable distance to San Jose, CA and work onsite several times per week.
What You Will Do
- Manage documentation requests to support global product registrations and coordinate with affiliates and regulatory authorities to enable timely approvals.
- Develop and obtain legally required documents for U.S. and international registrations, including Certificates of Foreign Government, Free Sales Certificates, and FDA listings.
- Build and maintain strong relationships with global regulatory affairs teams and cross‑functional partners to support registration needs and project efficiency.
- Create and implement project strategies to improve compliance, streamline regulatory submissions, and support large‑scale registration initiatives.
- Upload and maintain change‑control documentation within the global content management system and ensure accuracy of regulatory files.
- Coordinate technical and scientific regulatory activities required for international product submissions.
- Update and manage regulatory document archives (paper and electronic) to support audit readiness and regulatory accessibility.
- Prepare and support routine reports and communications with regulatory agencies to ensure alignment and submission quality.
What You Will Need
Required Qualifications
- Bachelor’s degree in Engineering, Science, or a related field.
- 0+ years of experience in regulatory affairs or a related technical discipline.
Preferred Qualifications
- Master’s degree in Regulatory Science or related field.
- Experience in regulatory affairs or a related technical discipline.
- Experience working with regulatory requirements or documentation processes for medical devices.
- Experience interacting with global regulatory bodies or content management systems.
$72,500 - $157,200 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
