Senior Regulatory Affairs Specialist Labeling

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 postmarket lifecycle. If you are energized by global impact crossfunctional 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 postmarket changes.
• Analyze emerging regulatory intelligence related to labeling and assess impacts to current and future products.
• Provide regulatory guidance on global labeling requirements to crossfunctional 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

• Bachelors degree in Science Engineering or a related discipline.
• 2 years of experience in a Regulatory Affairs role within an FDAregulated 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.

• $95800 - $159600 USD Annual