Senior Specialist Regulatory Affairs

Senior International Regulatory Affairs Specialist

Irvine, CA

Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role, you will support regulatory strategy, submissions, and product lifecycle activities across a range of projects, partnering with cross-functional teams to navigate regulatory requirements and maintain product compliance in global markets.

This position offers the opportunity to contribute to regulatory planning, agency interactions, and submission activities while collaborating with product development, quality, clinical, and manufacturing teams.

Work Flexibility:
Hybrid: candidates must reside within commuting distance of Irvine, CA and be able to work onsite several days per week.

What You Will Do

• Assess regulatory intelligence and regulatory requirements to support local, regional, and global regulatory strategies.
• Evaluate products, product changes, and manufacturing changes for regulatory classification, submission requirements, and compliance impact.
• Prepare, compile, and submit regulatory submissions and supporting documentation in accordance with applicable global regulations and guidelines.
• Monitor regulatory authority review activities and support communications with regulatory agencies throughout the submission process.
• Provide regulatory guidance to cross-functional teams throughout product development, manufacturing, clinical, and post-market activities.
• Review quality, preclinical, clinical, and manufacturing documentation to support regulatory submissions and compliance requirements.
• Identify regulatory risks, emerging requirements, and potential market access obstacles, and recommend solutions to support project timelines.

What You Will Need

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
• Minimum 2 years of experience in Regulatory Affairs.
• Experience preparing, reviewing, or supporting regulatory submissions and regulatory documentation.
• Experience interpreting and applying regulatory requirements within a regulated environment.

Preferred Qualifications

• Master's degree in Regulatory Science or a related field.
• Regulatory Affairs Certification (RAC).
• Experience supporting global regulatory submissions and regulatory authority interactions.
• Experience working with medical devices or other regulated healthcare products.

• $95,800 - $159,600 USD Annual