Regulatory Affairs Specialist
Masimo – Bengaluru, India
About Masimo:
Masimo is a global leader in advanced medical technology, dedicated to improving patient outcomes and reducing the cost of care. We are committed to innovation and excellence in the medical device industry.
About the Role:
We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team in Bengaluru. In this role, you will play a critical part in securing domestic regulatory approvals for our innovative medical technologies, ensuring compliance with FDA and international regulations. You will serve as the sole RA representative on multiple project teams, collaborating closely with marketing, clinical, and engineering departments. This is an excellent opportunity for a passionate and driven individual to make a significant impact in a dynamic and growing company.
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 a related field.
- 2+ years of 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.
- Understanding of ISO 13485, FDA/GMP compliance.
- Regulatory submissions experience for medical device software or electronics.
Benefits and 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)
How to Apply:
[Application Link]