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 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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.