oracle
Quality Regulatory Operations Specialist
Masimo
Bengaluru, IND
Full-time
Entry · 2+ years experience
Onsite
Discovered 3 weeks ago
RIMeQMSISO 13485
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RIMeQMSISO 13485
Key Skills for This Role
RIMeQMSISO 13485
Full Job Posting
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
About Masimo
Medical Device Manufacturing2200 employeesFounded 1989
Medical technology company developing noninvasive patient-monitoring technologies for clinicians and patients worldwide.
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