Regulatory Affairs Associate
1 week ago
Experience: 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 Documentation Strong knowledge of global regulatory frameworks: FDA QSR, ISO 13485, EU MDR, IEC standards Experience in DHF assessment and remediation Familiarity with FDA 21 CFR Part 820.30 and ISO 13485:2016 design control requirements Documentation skills – validation reports, change control, deviation records Strong communication skills, both written and verbal
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Regulatory Affairs Associate
2 weeks ago
tamil nadu, 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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Medical Device Regulatory Affairs Intern
1 week ago
Pappanaickenpalayam, Coimbatore, Tamil Nadu, India B-Arm Medical Technologies Private limited Full time**Job Title: Medical Device Regulatory Affairs Intern** **Overview** As a Medical Device Regulatory Affairs Intern, you will support managing the regulatory processes for medical devices. You will assist in preparing documentation, conducting research, and ensuring compliance with regulatory requirements. This internship provides a valuable opportunity to...
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Regulatory Affairs Executive
2 weeks ago
Ambattur, Chennai, Tamil Nadu, India Gesco Healthcare Pvt Ltd Full timeCompany Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...
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Regulatory Affairs Executive
2 weeks ago
Tambaram, Chennai, Tamil Nadu, India Regenix Biosciences Ltd Full timeExperience: 0 to 1 years of experience in Regulatory affairs. Qualification: B. Pharm / M. Pharm / MSc. Biotechnology Description: Regulatory Affairs Handling Dossiers License Queries CFT Communication Life cycle etc. *Immediate Joiners* Excellent in Communication Application Question(s): - Current CTC - Expected CTC - Notice...
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Regulatory Affairs Executive
2 weeks ago
Chennai, Tamil Nadu, India LUMBAR HEALTHTECH PVT LTD Full timeFull job description **Key Responsibilities**: - Monitor and stay up-to-date on regulatory changes and requirements in different regions. - Communicate with regulatory authorities and answer their queries or requests. - Ensure product labeling and packaging meet regulatory standards. - Maintain records of regulatory submissions, approvals, and...
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Clinical Affairs
4 days ago
Chennai, Tamil Nadu, India Meshira luxury Full time**Age limit:20 to 30.**: - **Clinical Study Design & Execution**: Leading the design and implementation of clinical study protocols and monitoring their progress. - **Regulatory Compliance**: Ensuring all activities, from clinical trials to post-market evaluations, adhere to regulatory requirements and guidelines (e.g., FDA regulations, GCP). - **Data...
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Junior Regulatory Associate
2 days ago
T Nagar, Chennai, Tamil Nadu, India HAWK TECHNOLOGIES PVT LTD Full timeProject Administration - Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions. - Provide basic regulatory affairs services...
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Manager - Corporate Affairs and Capital Planning
2 weeks ago
tamil nadu, India Johnson Electric Full timeJob Summary: We are looking for Manager - Government Affairs & Capital Planning, will be responsible for ensuring regulatory compliance, securing government approvals and incentives, and supporting capital project execution for Johnson Electric’s expanding operations in India. This role will play a critical part in the successful setup and consolidation of...
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Associate Ii
4 hours ago
Chennai, Tamil Nadu, India Pfizer Full timePrimarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post - approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) under the guidance of the team lead. The activities...
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Assistant Manager
3 days ago
Chennai, Tamil Nadu, India CIEL HR Full timeJob description Roles and Responsibilities - Ensure timely authoring and submission of dossiers Module 2-5 for regulated and ROW in the eCTD format including familiarity with publishing activities - Assessment of change controls defining the correct variation code and preparation of the variation packages as per the agreed timelines - Co-ordinate with...