{"@context":"https://schema.org","@type":"JobPosting","title":"Executive - Materiovigilance (Clinical Affairs & Regulatory)","description":"

Role & responsibilities

Monitors the company's medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution in compliance with government regulations.
Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
Ensure standard Post market surveillance (PMS) process
Responsible for ensuring consistent PMS plans and reports exists for all products
Responsible for ensuring consistent PSUR reports exists for all products
Responsible for ensuring consistent and standard process exists to perform proactive surveillance activities (Eg: regulatory databases search, literature review) and reactive surveillance (Eg: complaints handling, field actions including CAPA)
Responsible for attending both internal and external Audits
Responsible for Materiovigilance related Regulatory tasks related to State and Central Drugs Control Dept.

","datePosted":"2026-06-24T00:00:00.000Z","validThrough":"2026-08-23T00:00:00.000Z","employmentType":"FULL_TIME","identifier":{"@type":"PropertyValue","name":"myjobb-ai","value":"4354186"},"url":"https://myjobb.ai/jobs/executive-materiovigilance-clinical-affairs-regulatory/4354186","directApply":false,"hiringOrganization":{"@type":"Organization","name":"Healthium Medtech","logo":"https://static.ambitionbox.com/assets/v2/images/rs:fit:200:200:false:false/aHR0cHM6Ly9tZWRpYS5uYXVrcmkuY29tL21lZGlhL2FiY29tcGxvZ28vaGVhbHRoaXVtLW1lZHRlY2gtb3JpZ2luYWwuanBn.webp","sameAs":"https://www.healthiummedtech.com/"},"jobLocation":[{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bengaluru","addressRegion":"Karnataka","addressCountry":"India"}}]}