Regulatory Affairs
2 days ago
A Regulatory Affairs Associate in the medical device industry supports the development, registration, and compliance of medical devices throughout their lifecycle. level role ensures products meet regulatory standards set by bodies such as the FDA (U.R&D, Quality Assurance, Clinical, and Marketing) to prepare submissions, maintain documentation, and monitor regulatory changes, contributing to safe and timely market access for medical devices. Assist in preparing, reviewing, and submitting regulatory documents, Technical Support regulatory assessments for OBL’s product changes, labeling updates, and post- market activities, such as Medical Device Reporting (MDR), vigilance reporting, and field Maintain and update regulatory databases, tracking submissions, approvals, and renewals 14971 for risk management) and communicate impacts to OBLs. - Support post-market surveillance, including adverse event reporting and compliance with Bachelor’s degree in pharmacy. - Experience: 1–3 years in regulatory affairs, preferably in medical devices (Class I–III), pharmaceuticals, or a related regulated industry. FDA regulations (21 CFR Parts 803, 820, 814), EU Medical Device Understanding of medical device lifecycle, including design controls, clinical data Analytical mindset to evaluate regulatory risks and changes. -
-
Regulatory Affairs Associate
3 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 ...
-
Regulatory Affairs Associate
3 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...
-
Regulatory Affairs Associate
3 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...
-
Regulatory Affairs Associate
3 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...
-
Regulatory Affairs Associate
3 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-...
-
Regulatory Affairs Associate
1 week 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-...
-
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...
-
Regulatory Affairs Associate
4 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...
-
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...
-
Regulatory Affairs Associate
2 days ago
Madurai, India Aurolab Full timeJob Summary:A Regulatory Affairs Associate in the medical device industry supports the development,registration, and compliance of medical devices throughout their lifecycle. This entry-to-mid-level role ensures products meet regulatory standards set by bodies such as the FDA (U.S.),EU MDR (Europe), and other international authorities. The associate works...
