Regulatory Affairs Job at Masimo, USA | Life Sciences | Earn Upto $95,000/yr | Apply Now
In the fast-evolving MedTech ecosystem of 2026, Irvine, California, remains the “Silicon Heart” of patient monitoring technology. Securing a Regulatory Affairs Job at Masimo isn’t just about paperwork; it is about acting as the vital filter between cutting-edge engineering and global patient safety. As a Regulatory Affairs Specialist II, you will navigate the increasingly complex intersection of high-tech sensors, hospital software, and international law, ensuring that Masimo’s life-saving innovations reach the bedside without delay.
- Job Position: Regulatory Affairs Specialist II
- Location: Irvine, CA, United States
About the Company
Masimo is a global leader in non-invasive monitoring technologies. Known for their “can-do” culture and relentless innovation, they specialize in patient monitors, hospital-based products, and sophisticated software solutions. In 2026, as decentralized care and wearable health tech continue to peak, Masimo’s role in the market is more critical than ever. Choosing a Life Sciences Job at Masimo means working in a fast-paced, high-reward environment. The company’s Irvine headquarters offers world-class amenities, including an on-site wellness clinic, fitness center, and café, fostering a culture where technical excellence meets employee well-being.
Key Responsibilities: Navigating the Regulatory Affairs Job
In this role, you are the bridge between the “What if?” of Engineering and the “How?” of the FDA and EU MDR. You will lead the charge for domestic and international clearances, ensuring that products are compliant before they ever touch a patient.
- Submission Leadership: Draft and compile 510(k) Premarket Notifications and Technical Documentation Summaries for health authorities worldwide.
- Global Coordination: Work with regional teams to determine if product changes require new notifications or full regulatory approvals.
- System Stewardship: Manage document change orders via Agile and maintain regulatory databases to track global registration trends.
- Cross-Functional Guidance: Act as the RA representative in project meetings, providing expert input during the design phase to prevent “regulatory roadblocks” later in the lifecycle.
- A Regulatory Affairs Job at Masimo requires a high-functioning individual who can balance strict adherence to ISO 13485 with the speed of an innovative tech firm.”
Candidate Profile: Requirements for Regulatory Jobs
Masimo is looking for an individual who is not just a “box-ticker” but a strategic thinker who can handle the pressure of Class II and III medical device environments. This Life Sciences Job requires a “can-do” attitude and the ability to work with minimal supervision.
Minimum Qualifications
- Experience: At least 2 years of work experience in a medical device Class II/III environment.
- Regulatory Knowledge: Working knowledge of FDA regulations or international standards (e.g., EU MDR).
- Technical Background: Experience in patient monitor systems, hospital-based products, software, or electronic device products.
- Education: A Bachelor’s degree is required, preferably in Engineering, Life Sciences, or Regulatory Affairs. A Graduate degree is preferred.
- Systems Proficiency: Experience with FDA/GMP requirements and Quality Systems per ISO 13485.
Preferred Qualifications
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Agency Interaction: Direct experience interacting with regulatory bodies, such as a Notified Body.
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Proven Success: A history of successful CE Mark certification for a Class II device and experience with international product registrations.
Compensation & Total Rewards for this Life Sciences Job
Masimo offers a comprehensive financial and wellness package for those embarking on a Regulatory Affairs Job in 2026. This package is designed to support both professional growth and personal well-being.
- Salary Range: The anticipated base salary is $75,000 – $95,000 per year, depending on experience and education.
- Performance Bonus: This position qualifies for up to a 10% annual bonus based on company, department, and individual performance.
- Retirement & Insurance: 401(k) with company match, along with Medical, Dental, Vision, and Life/AD&D insurance.
- Family Support: Paid maternity leave and flexible spending accounts for healthcare and dependent care.
- On-site Amenities: Full access to the Irvine wellness clinic, fitness center, and company café.
- Time Off: Generous vacation, sick leave, and paid holiday entitlements.
In summary, the Regulatory Affairs Specialist II position is a definitive Regulatory Affairs Job for those ready to lead in the 2026 MedTech space. By securing this Life Sciences Job, you position yourself within an organization that values ingenuity, ownership, and integrity. Whether you are drafting a 510(k) or facilitating a meeting in Masimo’s state-of-the-art Irvine facility, your work ensures that medical technology is both innovative and safe for global use.
