Duties & Responsibilities:
Support RA/QA operations across JPAC, including maintaining compliance and documentation accuracy
Assist with tender support activities, including preparation and review of regulatory and quality documentation
Collaborate with Commercial and cross-functional teams to support timely submission of required documentation
Support regulatory intelligence activities, including tracking regulatory updates and assisting with impact assessments
Maintain and organize regulatory documentation and records in alignment with internal systems and requirements
Assist in Quality Management System (QMS) processes (ISO 13485), including CAPA tracking, change control, and audit preparation
Support internal and external audits, including documentation collection and coordination
Assist with complaint handling, vigilance, and post-market activities, including data tracking and documentation
Provide support for field actions and recalls, ensuring documentation and coordination activities are maintained
Assist with distributor/importer registrations and compliance activities across JPAC markets
Support labeling and claims review activities, ensuring documentation is compliant with regional requirements
Utilize regulatory and quality systems (RIM/eQMS) to maintain accurate records and support reporting
Contribute to process improvements and standardization initiatives
Minimum & Preferred Qualifications and Experience:
Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field
2–5 years of experience in Regulatory Affairs and/or Quality Assurance (medical device or healthcare preferred)
Basic understanding of JPAC regulatory frameworks (e.g., CDSCO, PMDA, TGA, HSA, NMPA)
Exposure to Quality Management Systems (ISO 13485) and related processes (CAPA, audits, change control)
Exposure to or interest in regulatory submissions and product lifecycle processes
Strong attention to detail and organizational skills
Good analytical and problem-solving abilities
Strong written and verbal communication skills
Ability to work effectively in a cross-functional environment
Familiarity with document management or regulatory systems (RIM/eQMS) is a plus
Skills Required
- 2 years work experience in a medical device Class II/III environment
- Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field
- 3-5+ years of regulatory affairs experience in medical device or healthcare industry
- Strong experience in JPAC regulatory environments
- Experience with regulatory submissions and approvals across multiple APAC countries
Masimo Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Masimo and has not been reviewed or approved by Masimo.
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Healthcare Strength — Comprehensive medical, dental, and vision coverage is offered alongside company‑paid life insurance at 2x salary and long‑term disability coverage. The package reflects broad core health protection.
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Leave & Time Off Breadth — Policies include 15 days of paid vacation to start, up to 10 paid holidays, 40 hours of sick time, and defined paid parental leave components. This structure provides clear, multi‑category time‑off coverage.
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Wellbeing & Lifestyle Benefits — An EAP, corporate discounts, and onsite amenities such as a café, wellness center, and gym are available at certain locations. These perks enhance day‑to‑day support where onsite access exists.
Masimo Insights
What We Do
Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve life, improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown to outperform other pulse oximetry technologies in over 100 independent and objective studies, which can be found at www.masimo.com/evidence/featured-studies/feature. Masimo SET® is estimated to be used on more than 200 million patients around the world each year and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2025 Newsweek World’s Best Hospitals listing. Additional information about Masimo and its products may be found at www.masimo.com.
