Quality Regulatory Operations Specialist

About the role

Regulatory Affairs at Masimo Americas supports compliance and quality operations across the JPAC region. The specialist maintains regulatory documentation, assists tender submissions, and contributes to ISO 13485 QMS processes while coordinating with commercial and cross‑functional teams. Bengaluru, India, on-site role with potential for regional travel.

What you’ll do

• Support RA/QA operations across JPAC ensuring compliance and documentation accuracy
• Assist with tender support activities and preparation of regulatory and quality documents
• Collaborate with commercial and cross‑functional teams for timely submissions
• Track regulatory updates and conduct impact assessments
• Maintain regulatory records and support QMS processes including CAPA and audits
• Assist with complaint handling, vigilance, and post‑market activities
• Support field actions, recalls, and distributor/importer registrations
• Contribute to process improvements and standardization initiatives

What you’ll bring

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering or related field
• 2-5 years experience in Regulatory Affairs or Quality Assurance
• Understanding of JPAC regulatory frameworks (CDSCO, PMDA, TGA, HSA, NMPA)
• Exposure to ISO 13485 Quality Management System
• Familiarity with regulatory submissions and product lifecycle
• Strong attention to detail and organizational skills
• Analytical and problem‑solving abilities
• Excellent written and verbal communication

Skills

Education

Bachelor’s degree