Apply Online for Regulatory Affairs Specialist at Masimo

In 1996, Masimo introduced Signal Extraction Technology® (SET®), the world’s first Measure-through Motion and Low Perfusion™ pulse oximetry. This breakthrough transformed pulse oximetry from a fair-weather friend into a reliable, trusted indicator of patient status. Building on that foundation and a legacy of innovation, Masimo continues to advance pulse oximetry, now through smartSET™—using AI-enabled pattern recognition to help clinicians detect the need for intervention sooner.

Post : Regulatory Affairs Specialist

Job Description
• Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files, tender request submission and any audit finding responses.
• Communicate with headquarter regulatory team on local regulation changes with impact assessment.
• Assist in communications with global regulatory representatives to assist in filings and responses to inquiries from health authorities.
• Assist in maintaining product listings and establishment registrations with India regulatory authorities.
• Familiar with BIS requirements and supporting import/exports for medical devices.
• Assist in maintaining regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements.
• Maintain up-to-date knowledge on international and domestic regulatory requirements.
• Provide regulatory support to the OEM Product Management team
• Submit sales market change orders (SMCO/agile) for approvals.
• Support impact assessment for changes anticipated by Corporate.
• May represent RA department in project meetings and provide regulatory guidance.
• Update RA responsible quality system procedures as required (SQP/SOP’s);
• Performs other duties or special projects as assigned.

Candidate Profile
• A minimum of 2 years of work experience in a medical device Class II/ III environment.
• Local Indian Regulatory experiences in medical device industry are required
• Working knowledge of IT equipment import/export rule and BIS certs application process.
• Computer Proficiency with MS Office (Word/Excel/Access/Outlook).
• Excellent verbal and written communication skills.
• Excellent prioritizing, organizational, and interpersonal skills.
• Excellent documentation skills including record maintenance/ tracking and understand document traceability.
• A detail-oriented individual with a “can do” attitude and 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/projects.
• Ability to work in a Project Team Environment.

Additional Information
Experience : 2 years
Qualification : Bachelor’s degree is required, preferably in Engineering or Life Sciences. Graduate degree preferred.
Location : Bengaluru
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September 2026