summary

bengaluru, karnataka
permanent

job category
engineering

job details

Required Attributes :

Master’s degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field.
6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry.
In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO.
Proven experience in leading regulatory submissions and successful product registrations in international markets (EU, US, India, etc.).
Experience in managing audits, including Notified Body inspections, CDSCO/FDA audits, and internal audits.

experience

10 ...

Required Attributes :

Master’s degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field.
6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry.
In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO.
Proven experience in leading regulatory submissions and successful product registrations in international markets (EU, US, India, etc.).
Experience in managing audits, including Notified Body inspections, CDSCO/FDA audits, and internal audits.

experience

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test manager
- bengaluru, karnataka
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Required Skills & Experience:Technical / Domain Skills• 12-15 years of experience in software testing, with at least 3+ years in Test Management.• Strong exposure to pharma / life-sciences / healthcare domain, especially in LIMS, Clinical, or Regulatory applications.• Sound understanding of CSV, GxP, and FDA 21 CFR Part 11 compliance.• Hands-on experience with test management tools (ALM, Azure DevOps, JIRA) and automation frameworks (Selenium, Tosca, UFT).
posted 17 november 2025
Required Skills & Experience:Technical / Domain Skills• 12-15 years of experience in software testing, with at least 3+ years in Test Management.• Strong exposure to pharma / life-sciences / healthcare domain, especially in LIMS, Clinical, or Regulatory applications.• Sound understanding of CSV, GxP, and FDA 21 CFR Part 11 compliance.• Hands-on experience with test management tools (ALM, Azure DevOps, JIRA) and automation frameworks (Selenium, Tosca, UFT).
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- bengaluru, karnataka
- permanent
This role is based at TKM MQE in a General Shift and involves critical work in ensuring the quality of our materials. Key responsibilities include:Material Quality Assurance and control.Supplier Interaction and Material Issue Resolution.In House Quality Check.Required Candidate ProfileWe are looking for a candidate who meets the following criteria:Vacancy: Engineer.Experience: Minimum 2-4Years.Education: BE - Chemical or Mechanical Engineering.Age Group: 2
posted 7 november 2025
This role is based at TKM MQE in a General Shift and involves critical work in ensuring the quality of our materials. Key responsibilities include:Material Quality Assurance and control.Supplier Interaction and Material Issue Resolution.In House Quality Check.Required Candidate ProfileWe are looking for a candidate who meets the following criteria:Vacancy: Engineer.Experience: Minimum 2-4Years.Education: BE - Chemical or Mechanical Engineering.Age Group: 2
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sr. engineer quality
- bengaluru, karnataka
- permanent
Understand technical documents, including drawings, inspection standards, and quality documents.Analyze problems by understanding the gap between standard requirements and actual conditions.Perform technical analysis for problem-solving and root cause analysis.Conduct Parts & Vehicle Inspection Assurance Control.Enhance Vehicle Quality through Technical Analysis, leading to parts/process level up.Ensure Outflow Assurance Enhancement for Parts Rank A defect
posted 6 november 2025
Understand technical documents, including drawings, inspection standards, and quality documents.Analyze problems by understanding the gap between standard requirements and actual conditions.Perform technical analysis for problem-solving and root cause analysis.Conduct Parts & Vehicle Inspection Assurance Control.Enhance Vehicle Quality through Technical Analysis, leading to parts/process level up.Ensure Outflow Assurance Enhancement for Parts Rank A defect
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quality regulatory manager.

job details

Required Attributes :

Master’s degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field.

6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry.

In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO.

Proven experience in leading regulatory submissions and successful product registrations in international markets (EU, US, India, etc.).

Experience in managing audits, including Notified Body inspections, CDSCO/FDA audits, and internal audits.

experience

Required Attributes :

Master’s degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field.

6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry.

In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO.

Proven experience in leading regulatory submissions and successful product registrations in international markets (EU, US, India, etc.).

Experience in managing audits, including Notified Body inspections, CDSCO/FDA audits, and internal audits.

experience

share this job.

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getting you registered.

compliance check.

reference and background check.

the perfect job for you.

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supplier quality assurance

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