Regulatory Affairs Job at Masimo | Life Sciences | Apply Now
Masimo, a global leader in innovative noninvasive monitoring technologies, is hiring a Regulatory Affairs Specialist for its Bengaluru operations. This Regulatory Affairs Job is a strategic role focused on managing medical device registrations, ensuring compliance with Indian health authorities, and supporting international filings within the APAC region. This position is an ideal fit for professionals seeking a high-impact Life Sciences Job that combines technical documentation, legal compliance, and cross-functional project management.
- Job Position: Regulatory Affairs Specialist
- Job ID: 3548.
- Location: Bengaluru, India.
- Job Category: Regulatory Affairs (Full-time)
About the Company
Masimo is an industry leader known for its “Pulse CO-Oximetry” and advanced patient monitoring solutions. The company is committed to diversity and offers an environment where RA professionals can manage complex projects involving patient monitor systems, hospital-based products, and software-driven medical devices.
Key Responsibilities & Compliance Scope
The role serves as a critical bridge between local Indian regulations and Masimo’s global headquarters.
- Filing & Registration: Support the APAC team in drafting technical files, submitting tender requests, and responding to health authority inquiries or audit findings.
- Domestic Compliance: Assist in maintaining product listings and establishment registrations with Indian regulatory authorities. This includes managing BIS (Bureau of Indian Standards) requirements for medical and IT equipment.
- Strategic Communication: Assess the impact of local regulation changes and communicate findings to the global headquarters. Represent the RA department in project meetings to provide guidance.
- Change Management: Submit Sales Market Change Orders (SMCO/Agile) and support impact assessments for corporate-level changes.
- System Maintenance: Update Quality System procedures (SOPs/SQPs) and maintain regulatory databases to track filing timelines and compliance KPIs.
Qualifications & Experience Profile
This documentation job requires a high level of precision and a deep understanding of the medical device lifecycle.
- Education: Bachelor’s degree (required), preferably in Life Sciences or Engineering. A Graduate degree is highly preferred.
- Minimum Experience: At least 2 years of work experience in a medical device Class II/III environment with specific experience in the Indian regulatory landscape.
- Technical Knowledge: Familiarity with ISO 13485 Quality Systems and IT equipment import/export rules.
- Skills: Proficiency in MS Office (Word, Excel, Access) and excellent documentation skills, including record maintenance and traceability.
- Core Objective: Managing technical files, domestic registrations (CDSCO), and BIS certifications for Class II and III medical devices.
Advancing your career with a Regulatory Affairs Job at Masimo provides a global platform to master the complexities of the Indian medical device market. This Life Sciences Job in Bengaluru is perfect for detail-oriented individuals who excel at a high-stakes documentation job and cross-functional teamwork. If you possess the required experience in Class II/III devices and BIS certifications, Masimo offers a fast-paced environment to grow your expertise.
