Senior Regulatory Affairs Specialist – Labeling

Irvine, CA

In this role, you will help shape and maintain accurate, compliant medical device labeling across global markets, supporting products from development through the post‑market lifecycle. If you are energized by global impact, cross‑functional collaboration, and meaningful work in a regulated environment, this role offers an opportunity to grow while making a difference.

What You Will Do

• Evaluate medical device labeling to ensure compliance with global regulatory requirements and standards, supporting market access and patient safety.
• Prepare, review, and maintain labeling content across the full product lifecycle for multiple global markets.
• Support new product development by contributing labeling elements to regulatory submissions for global registrations.
• Maintain sustaining registrations through labeling updates, renewals, and post‑market changes.
• Analyze emerging regulatory intelligence related to labeling and assess impacts to current and future products.
• Provide regulatory guidance on global labeling requirements to cross‑functional partners, enabling timely and compliant decisions.
• Support global regulatory submissions by preparing and submitting documentation in alignment with applicable regulatory requirements.
• Participate in internal and external audits and contribute to the development and improvement of regulatory procedures and labeling processes.

What You Will Need

Required Qualifications

• Bachelor’s degree in Science, Engineering, or a related discipline.
• 2+ years of experience in a Regulatory Affairs role within an FDA‑regulated or similarly regulated industry.

Preferred Qualifications

• Experience preparing medical device labeling aligned with global standards and regulations (e.g., ISO and U.S. regulations).
• Experience supporting Class I, Class II, and/or Class III medical devices.
• Experience supporting U.S. and international regulatory submissions.
• Prior interaction with regulatory agencies.
• RAC certification and/or an advanced degree in Regulatory Affairs or a related field.

• $95,800 - $159,600 USD Annual