"Regulatory Affairs Specialist Job at Masimo, Bengaluru – Apply Now | Medical Device RA Careers 2025-26"
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(Masimo Regulatory Affairs Specialist Job in Bengaluru 2025-26) |
The medical device industry continues to grow rapidly, and with this growth comes the increasing need for highly skilled regulatory professionals. If you are an experienced Regulatory Affairs Specialist looking to make an impact in a global organization, this opportunity at Masimo could be a breakthrough in your career. Masimo is a world-renowned leader in advanced monitoring technologies, including noninvasive sensors, patient monitoring systems, and clinically proven medical devices used across hospitals worldwide.
The company is now hiring a Regulatory Affairs Specialist in Bengaluru, India, offering a high-growth career path for professionals who understand regulatory submissions, 510(k) filings, global certifications, and compliance frameworks. If you are someone who works with precision, values innovation, and enjoys building regulatory strategies—this role is designed for you.
About Masimo:-
Masimo is globally respected for transforming patient care through breakthrough medical technologies. Their portfolio includes advanced monitoring systems, sensor technologies, wireless solutions, and patient safety innovations used by clinicians all around the world. With a strong commitment toward regulatory compliance and product quality, Masimo ensures that every medical device meets the most stringent standards before reaching hospitals and healthcare professionals.
Working at Masimo means being part of a team that saves lives every day through technology and innovation. For regulatory affairs professionals, the company offers exposure to global regulatory bodies, advanced medical products, and world-class compliance systems.
Role Overview – Regulatory Affairs Specialist:-
The Regulatory Affairs Specialist will play a key role in ensuring that Masimo’s innovative medical technologies meet both domestic and international regulatory standards. As part of the regulatory team, you will be responsible for managing product submissions, ensuring documentation accuracy, and coordinating with global regulatory authorities.
This role demands strong analytical skills, excellent communication, and a deep understanding of the regulatory landscape related to Class II and Class III medical devices. You will act as a key regulatory representative for various internal projects and ensure timely approvals for new and existing products.
Key Responsibilities:-
As a Regulatory Affairs Specialist at Masimo, your responsibilities will include:
Preparing and submitting 510(k) Premarket Notifications for medical devices
Managing regulatory submissions for global markets, including Europe, Asia, and the Middle East
Coordinating product registrations and certifications required for domestic and overseas markets
Communicating with notified bodies and regulatory authorities regarding device compliance
Updating product listings, technical files, declarations, and compliance certifications
Monitoring changes in FDA, EU MDR, and international regulatory requirements
Supporting risk assessment documentation, such as FMEA, FTA, and hazard analysis
Maintaining high-quality regulatory documentation and audit-ready records
Participating in project meetings as the primary RA representative
Assisting QA teams with OEM documentation, corrective actions, and SOP updates
These responsibilities require a professional who is detail-oriented, proactive, and capable of managing multiple deadlines.
Qualifications & Skills Required:-
✔ Minimum Requirements:
Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Pharmacy, or related fields
Minimum 2 years of experience in medical device regulatory affairs
Strong working knowledge of FDA regulations, 510(k) submissions, and global compliance
Familiarity with Class II & Class III medical devices
Proficiency in Microsoft Office and regulatory documentation tools
Ability to multitask while maintaining accuracy and regulatory precision
✔ Preferred Experience:
Knowledge of patient monitoring systems and hospital-grade medical devices
Experience with ISO 13485, FDA/GMP, and quality management systems
Experience with medical device software or electronic instrumentation
Exposure to global regulatory authorities or notified bodies
Benefits of Working at Masimo:-
Competitive salary with performance-driven growth opportunities
Exposure to cutting-edge medical device technology
A collaborative environment with top-tier engineering, clinical, and regulatory teams
Opportunities to work on global projects and international submissions
Workplace culture that values diversity, inclusion, and innovation
Job Location:-
Bengaluru, India
Full-time | On-site role
Salary (Estimated Range):-
The salary for this position is expected to fall between:
👉 ₹8,00,000 to ₹14,00,000 per annum, depending on experience and skill level.
How to Apply:-
Interested candidates can apply directly through Masimo’s official application portal:
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