Masimo, a Danaher operating company, is hiring for the position of Regulatory Affairs Specialist in Bengaluru, India. This opportunity is suitable for professionals with experience in medical device regulatory affairs, Indian regulatory submissions, and product registration.
The selected candidate will support domestic and international regulatory filings, obtain Indian regulatory clearances for medical devices, and coordinate with regional and global regulatory teams. The position is eligible for remote work.
Masimo Recruitment 2026 – Job Details
| Particulars | Details |
|---|---|
| Company | Masimo |
| Parent Company | Danaher |
| Job Title | Regulatory Affairs Specialist |
| Job Requisition ID | R1320374 |
| Location | Bengaluru, India |
| Job Type | Full-time |
| Work Mode | Remote work eligible |
| Industry | Medical Devices / Healthcare Technology |
| Experience | Minimum 2 years in a medical device Class II/III environment |
| Application Mode | Online |
Position Overview
The Regulatory Affairs Specialist will manage and document Indian regulatory clearances for medical device products. The role also involves supporting new product launches and product changes, preparing regulatory documentation, and maintaining registrations with Indian regulatory authorities.
Roles and Responsibilities
- Support APAC regulatory teams with domestic and international filings and registrations.
- Draft and compile technical files for regulatory submissions.
- Support tender request submissions and responses to audit findings.
- Communicate regulatory changes in India to headquarters and assess their impact.
- Coordinate with global regulatory representatives on filings and responses to health authority inquiries.
- Maintain product listings and establishment registrations with Indian regulatory authorities.
Eligibility Criteria and Qualifications
Candidates must meet the following requirements:
- Minimum 2 years of work experience in a medical device Class II/III environment.
- Experience in Indian regulatory affairs within the medical device industry.
- Working knowledge of IT equipment import/export rules.
- Knowledge of the BIS certification application process.
Preferred Skills and Experience
The following experience would be an added advantage:
- Patient monitoring systems and hospital-based products.
- Software or electronic device products.
- Regulatory submission requirements for Class II medical devices in India.
- Quality systems under ISO 13485.
Required Skills
- Medical device regulatory affairs and product registration.
- Regulatory documentation and technical file preparation.
- Knowledge of Indian regulatory requirements.
- Regulatory change assessment.
- Coordination with regional and global regulatory teams.
- Ability to travel as required.
Work Arrangement and Benefits
The position is eligible for a remote working arrangement, with additional details provided during the interview process.
Masimo also offers employee benefit programs that may include healthcare coverage and paid time off.
How to Apply
