Quality Regulatory Operations Specialist

Masimo Corporation; Bengaluru; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Masimo Corporation is seeking a Quality Regulatory Operations Specialist to support RA/QA across JPAC, ensuring regulatory compliance and accurate documentation. The role involves preparing and reviewing regulatory and quality documents, coordinating with cross-functional teams, and supporting QMS processes under ISO 13485.

You will track regulatory updates, assist with audits, and help manage complaints, field actions, and recalls, while maintaining records in RIM/eQMS systems and contributing

Qualifications

• 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 regulatory submissions and product lifecycle processes.
• 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.

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.

Skills

Regulatory Affairs

Quality Assurance

Cross-functional collaboration

Regulatory intelligence

Documentation management

Education

Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field

Tools

RIM

eQMS

Job description

Quality Regulatory Operations Specialist

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Job Description

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