Regulatory Affairs Specialist
Regulatory Affairs Specialist
Masimo
Job description
Looking for a Regulatory Affairs Specialist role in the medical device industry? Here's a simple guide to the job, its duties, and how to apply.
Company Description
Masimo is a medical technology company that is famous for changing how patient monitoring is done. Its Signal Extraction Technology fixed a problem that had been around for a time in pulse oximetry. This technology helps doctors keep track of patients accurately even when the patients are moving. Masimo is based in Irvine, California. It also has a big presence, in Bengaluru. They keep making tools, including systems that use artificial intelligence to help doctors respond more quickly when patients need treatment.
Job Summary
This role sits within Masimos growing Regulatory Affairs team, based in Bengaluru. As a Regulatory Affairs Specialist you will support both international filings for Masimos innovative medical devices. Regulatory Affairs Specialist will work closely with the regulatory teams. They will keep track of any changes to products. They will also make sure that all requirements specific to India are current and up to date. This job requires someone who is organized and who can handle tasks at the same time. The Regulatory Affairs Specialist needs to be good, at staying organized.
Key Responsibilities
Support the regional regulatory team in managing filings and registrations for India.
Help draft and organize technical files needed for submissions.
Support responses to tender requests and audit findings.
Share updates on local regulation changes with the global regulatory team.
Help communicate with global regulatory contacts to support filings and queries.
Maintain accurate product listings and registrations with Indian authorities.
Prepare and file India specific regulatory submissions within set deadlines.
Work closely with Engineering, Marketing, and other teams to complete submissions.
Support scheduling and coordination for regulatory meetings.
Assist the wider regulatory team with everyday project needs.
Take on other duties or special projects as assigned.
Educational Qualification
Bachelor's degree required, preferably in Life Sciences or Engineering.
A Graduate degree is considered a strong plus.
Skills Required
Around 2 years of experience in a medical device Class II or III setting.
Good knowledge of Indian regulatory rules and ISO 13485 standards.
Comfortable using MS Office tools, including Word, Excel, and Access.
Strong documentation skills, with a clear focus on accuracy and traceability.
Excellent written and verbal communication skills.
Strong organizational skills and the ability to manage multiple projects.
A detail oriented mindset with a positive, can do attitude.
Experience with patient monitoring systems is a helpful bonus.
Salary Structure
The expected salary for a Regulatory Affairs Specialist at Masimo in India clustering around ₹5 Lakhs to ₹8 Lakhs per annum.
Career Development
This role offers strong exposure to both local and global regulatory work within a leading medical technology company. With hands on experience across real product filings, it opens a clear path toward more senior roles in regulatory affairs.
How to Apply
Visit our job portal and search for the Regulatory Affairs Specialist role - Masimo.
Click on the job posting to see all the details, about the job.
Fill in your information and upload your updated resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.