Are you a regulatory affairs professional looking for a high-impact role in the medical device industry? Masimo, a global leader in advanced medical technology, is hiring a Regulatory Affairs Specialist in Bengaluru. This role requires experience with medical device regulatory submissions, 510(k) filings, and compliance with FDA and international regulations.
This opportunity is ideal for candidates passionate about compliance, innovation, and ensuring life-saving medical devices meet regulatory standards. If you’re skilled in regulatory documentation, quality systems, and submission management—this role could be the next major step in your career.
🏢 About the Role
As a Regulatory Affairs Specialist, you will be responsible for securing domestic regulatory approvals for Masimo’s innovative medical technologies. You will serve as the sole RA representative on multiple project teams and collaborate closely with marketing, clinical, and engineering departments.
🧪 Key Responsibilities
- Prepare and submit 510(k) Premarket Notifications and related regulatory files
- Coordinate global product registrations and regulatory submissions
- Communicate with regulatory authorities and notified bodies
- Maintain product listings, certificates, and regulatory compliance records
- Track regulatory changes and implement compliance requirements
- Support risk assessments including FMEA, FTA, and related documentation
- Update SOPs and regulatory processes as needed
- Assist with QA documentation, OEM support, and project meetings
🎓 Qualifications
Minimum Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 2+ years experience in medical device regulatory affairs (Class II/III)
- Strong knowledge of FDA and international medical device regulations
- Excellent communication, organization, and multitasking skills
- Proficiency with Microsoft Office tools
Preferred Experience
- Exposure to patient monitoring systems and hospital-grade devices
- ISO 13485, FDA/GMP compliance understanding
- Regulatory submissions for medical device software or electronics
💼 Benefits & Work Environment
- Competitive salary and growth-oriented environment
- Work in a modern office setting with collaborative teams
- Exposure to global medical device compliance and regulatory bodies
- Diversity- and EOE-friendly workplace
📍 Job Location
📌 Bengaluru, India
Full-time | On-site
💰 Salary (Expected Range)
👉 ₹8–14 Lakhs per annum (Based on experience & skills)
