International Regulatory Affairs Specialist

International Regulatory Affairs Specialist

San Jose CA

Join a team that plays a key role in bringing lifechanging medical technologies to patients around the 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 crossfunctional partners to support registration needs and project efficiency.
• Create and implement project strategies to improve compliance streamline regulatory submissions and support largescale registration initiatives.
• Upload and maintain changecontrol 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

• Bachelors degree in Engineering Science or a related field.
• 0 years of experience in regulatory affairs or a related technical discipline.

Preferred Qualifications

• Masters 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.

$72500 - $157200 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.