Regulatory Affairs Jobs: Masimo Hiring Regulatory Specialist
Looking for high-growth regulatory affairs jobs in the biotech and medical device sector? Masimo offers a powerful career opportunity for professionals aiming to build a future in biotech jobs and life sciences jobs. As a Regulatory Affairs Specialist, you’ll drive regulatory clearances, manage 510(k) submissions, support global registrations, and collaborate with engineering and clinical teams. This role gives you hands-on exposure to FDA compliance, product documentation, and international regulatory systems—making it a perfect next step for ambitious life science graduates and regulatory professionals.
- Job Title: Regulatory Affairs Specialist
- Location: Bengaluru, India
About the Company:
Masimo is a global leader in innovative medical technology, known for revolutionizing patient monitoring and advancing healthcare safety standards. With a strong culture of innovation, Masimo empowers professionals to grow, contribute, and shape the future of medical device development and regulatory excellence.
Job Overview:
This role involves obtaining domestic regulatory clearances, preparing 510(k) submissions, supporting technical documentation, and providing regulatory guidance across product development teams. You will ensure compliance with FDA requirements while supporting product listings, registrations, and regulatory communications.
Educational Requirements:
- Bachelor’s degree in Life Sciences (required) or Engineering
- Graduate degree preferred
- Knowledge of regulatory systems for Class II/III medical devices
Key Responsibilities:
- Prepare and compile 510(k) Premarket Notifications and technical files
- Support international and domestic regulatory submissions
- Coordinate with global regulatory teams
- Maintain product listings, certifications, and FDA registrations
- Manage regulatory databases, compliance checklists, and reports
- Participate in risk analysis, FMEA, and quality documentation
- Provide regulatory input in cross-functional project meetings
- Update RA quality system procedures (SQP/SOPs)
Skills Required:
- Knowledge of FDA and international regulatory guidelines
- Experience with medical device Class II/III filings
- Documentation, analysis, and communication skills
- Ability to multitask in fast-paced environments
- Proficiency in MS Office tools
- Team-oriented mindset with strong ownership and detail orientation
This position offers an exceptional pathway for life science and engineering professionals to build a rewarding regulatory career in the medical device industry. With exposure to international regulations, 510(k) filings, and advanced product development, Masimo provides the ideal platform to grow and excel in the regulatory ecosystem.
