Regulatory Affairs Jobs: Masimo is Hiring a Specialist | Apply Now
If you are looking for a challenging and growth-oriented Regulatory Affairs Job in the medical device industry, this opportunity at Masimo, Bengaluru offers an excellent platform. With a focus on global compliance, technical documentation, and cross-functional collaboration, this RA Job role is ideal for professionals seeking life science jobs to build a strong and highly responsible career.
Job Details:
- Job Title: Regulatory Affairs Specialist
- Location: Bengaluru, India
- Job Identification: 3548
About the Company
Masimo is a global medical technology leader known for pioneering non-invasive monitoring solutions and advanced patient-care technologies used in hospitals, clinics, and critical care environments worldwide. With a strong commitment to innovation, accuracy, and safety, Masimo develops high-impact medical devices that support clinical decision-making and improve patient outcomes.
The company’s technology portfolio includes pulse oximetry, patient monitoring systems, wireless solutions, and advanced sensor-based devices designed to elevate healthcare standards. Masimo maintains a robust global regulatory framework and adheres to the highest quality standards, making it a preferred workplace for professionals seeking impactful roles in Regulatory Affairs and life science jobs.
With operations across multiple countries and a culture focused on scientific excellence, regulatory compliance, and continuous
improvement, Masimo offers an exceptional platform for individuals building their careers in RA jobs and medical device innovation.Key Responsibilities
- Support regulatory team in drafting and compiling 510(k) submissions, technical files, STED documents.
- Coordinate with regional RA teams regarding product changes and regulatory notifications.
- Assist in communication with global health authorities and notified bodies.
- Assist with generating Certificates of Foreign Government, Free Sale Certificates, and other regulatory documentation.
- Maintain product listings and establishment registrations with the FDA.
- Update and manage regulatory databases and summary reports.
- Stay updated on national and international regulatory requirements.
- Generate and maintain product compliance checklists.
- Provide regulatory support to OEM deployment teams.
- Work with QA/Engineering to create risk analysis, FMEA, FTA reports.
- Submit document change orders for approvals.
- Represent RA team in project meetings and provide regulatory guidance.
- Update RA quality system procedures (SQP/SOPs) as needed.
- Perform additional duties or special projects as assigned.
Education
Bachelor’s degree is required, preferably in Engineering or Life Sciences. Graduate degree preferred.
Minimum Qualifications
- 2+ years of experience in medical device Class II/III regulatory environment.
- Local Indian Regulatory Affairs experience.
- Working knowledge of FDA and international regulations.
- Proficiency with MS Office tools.
- Strong communication, documentation, and organizational skills.
- Ability to work independently and in a team environment.
- Ability to manage multiple tasks in a fast-paced environment.
Preferred Qualifications:
- Experience with patient monitoring systems or software-based devices.
- Knowledge of FDA Class II device submissions.
- Understanding of ISO 13485 and FDA/GMP regulatory frameworks.
- Experience with UL/ETL certification processes.
- Interaction experience with notified bodies.
This Regulatory Affairs Specialist role at Masimo presents an excellent career path for motivated professionals aiming to strengthen their expertise in RA jobs, global device regulations, and cross-functional collaboration. If you want to grow in the medical device regulatory sector and contribute to high-impact healthcare innovations, this life science job is a perfect fit.
