Regulatory Affairs Associate
2 days ago
Preferred candidate profile
Qualifications/ JD:
- Bachelor's degree in Mechanical / Biomedical / SW /HW Engineering, Quality Assurance, Regulatory Affairs, or a related field.
- In-depth understanding of medical device regulations, including FDA 21 CFR Part and ISO 13485:2016 requirements for design controls and DHF.
- Experience with risk management principles (e.g., ISO and their application to DHF.
- Experience with DHF remediation projects, especially for legacy products and/or in response to regulatory changes.
- Experience with Quality Management Systems (QMS) software and tools for DHF management (e.g., TcU, SAP PLM) is a plus.
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Regulatory Affairs Associate
2 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation...
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Regulatory Affairs Associate
2 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation...
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Regulatory Affairs Associate
2 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance , Regulatory Affairs , and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs , Quality Assurance , or ...
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Regulatory Affairs Associate
2 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation...
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Regulatory Affairs Associate
2 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance , Regulatory Affairs , and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs , Quality Assurance , or ...
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Regulatory Affairs Associate
2 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation-...
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Regulatory Affairs Associate
3 days ago
madurai, India HCLTech Full timeExperience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation-...
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Regulatory Affairs Associate
2 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 years Education: Bachelor's degree in Biomedical, Mechanical, or B.Pharm We are looking for talented professionals for roles in Quality Assurance , Regulatory Affairs , and Documentation in the Medical Devices domain. Skills & Requirements: Minimum 3 years of experience in Medical Devices Regulatory Affairs , Quality Assurance , or...
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Regulatory Affairs Associate
3 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 years Education: Bachelor's degree in Biomedical, Mechanical, or B.Pharm We are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain. Skills & Requirements: Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or...
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Regulatory Affairs Associate
2 weeks ago
Madurai, India HCLTech Full timeExperience: 2 to 5 years Education: Bachelor's degree in Biomedical, Mechanical, or B.Pharm We are looking for talented professionals for roles in Quality Assurance , Regulatory Affairs , and Documentation in the Medical Devices domain. Skills & Requirements: Minimum 3 years of experience in Medical Devices Regulatory Affairs , Quality Assurance , or...