Masimo is hiring a Regulatory Affairs Specialist for its Bengaluru location. The role is focused on medical device regulatory filings, registrations, BIS requirements, regulatory databases, and coordination with local and global regulatory teams.

Job Overview

• Position: Regulatory Affairs Specialist
• Company: Masimo
• Location: Bengaluru, India
• Job Category: Regulatory Affairs
• Job Identification: 3784
• Job Schedule: Full time
• Posting Date: 07/24/2026, 09:15 AM

Key Responsibilities

• Support the APAC regulatory team in managing international and domestic filings and registrations, including drafting and compiling technical files, tender request submissions, and audit finding responses.
• Communicate with the headquarter regulatory team regarding local regulation changes and impact assessments.
• Assist global regulatory representatives with filings and responses to inquiries from health authorities.
• Assist in maintaining product listings and establishment registrations with India regulatory authorities.
• Support BIS requirements and import/export activities for medical devices.
• Maintain regulatory databases and summary reports to help management track and trend filing and registration requirements.
• Maintain up-to-date knowledge of international and domestic regulatory requirements.
• Provide regulatory support to the OEM Product Management team.
• Submit sales market change orders, including SMCO/agile, for approvals.
• Support impact assessment for changes anticipated by Corporate.
• Represent the Regulatory Affairs department in project meetings and provide regulatory guidance when required.
• Update Regulatory Affairs responsible quality system procedures, including SQP/SOPs, as required.
• Perform other duties or special projects as assigned.

Minimum Qualifications and Experience

• A minimum of 2 years of work experience in a medical device Class II/III environment.
• Local Indian Regulatory experience in the medical device industry is required.
• Working knowledge of IT equipment import/export rules and BIS certification application process.
• Computer proficiency with MS Office, including Word, Excel, Access, and Outlook.
• Excellent verbal and written communication skills.
• Excellent prioritizing, organizational, and interpersonal skills.
• Strong documentation skills, including record maintenance/tracking and understanding of document traceability.
• Detail-oriented approach with a “can do” attitude.
• Ability to work in a team environment as well as individually with minimal supervision.
• Ability to work in a fast-paced environment with multiple tasks and projects.
• Ability to work in a project team environment.

Preferred Qualifications

• Experience in patient monitor systems, hospital-based products, software, or electronic device products.
• Knowledge of regulatory submission requirements for India Class II medical devices.
• Experience in Quality Systems per ISO 13485.

Educational Qualification

• Bachelor’s degree is required, preferably in Engineering or Life Sciences.
• Graduate degree preferred.

Work Environment

• This position primarily works in an office environment.
• The role requires frequent sitting, standing, and walking.
• Daily use of a computer and other computing and digital devices is required.
• Some local travel is necessary, and the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

Salary and Benefits

Salary details have not been provided in the job posting.

How to Apply

Interested candidates can apply online through the official Masimo careers page using the link below.