▷ (Immediate Start) Senior Operations Executive - Medical Device Regulatory
2 days ago
Job Description Experience: 1-2 years Location: Rohini Sector-3, New Delhi Company: ELT Corporate Private Limted About us: We are a leading consultancy providing comprehensive regulatory affairs and compliance services for medical devices across India and international markets including UAE, USA (USFDA), and Europe (CE / EU MDR). Our mission is to help manufacturers achieve seamless product registrations and global market access with speed, accuracy, and compliance excellence. Key Responsibilities: - Prepare, review, and submit regulatory documentation for medical device registration and approvals in India and international markets (UAE, USA, Europe). - Manage CE marking and EU MDR submissions, including technical file compilation and liaison with Notified Bodies. - Handle USFDA 510(k), De Novo, and PMA submissions, including pre-submission meetings and correspondence. - Support UAE MOHAP / SFDA / TGA / other GCC regulatory filings and country-specific dossiers. - Stay updated with global regulatory changes and advise clients accordingly. - Communicate with clients, regulatory authorities, and other stakeholders to ensure timely approvals. - Review product labeling, IFUs, and promotional materials for compliance. Required Qualifications & Experience: - Bachelor's / Master's degree in Biomedical Engineering, Pharmacy, Life Sciences, or related discipline. - 1-2 years of experience in Regulatory Affairs for medical devices (mandatory). - Proven experience in global submissions USFDA, EU MDR, CE marking, and UAE MOHAP or other GCC markets. - Strong understanding of ISO 13485, ISO 14971 (Risk Management), and GMP requirements. - Excellent written and verbal communication skills in English. - Proactive, detail-oriented, and able to handle multiple projects simultaneously. What We Offer: - Opportunity to work on diverse international projects. - Exposure to multi-country regulatory frameworks. - Professional growth in a fast-expanding consultancy. - Supportive and flexible work environment.
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Medical Device Regulatory Lead
4 weeks ago
New Delhi, India ArtiXio Full timeAbout the RoleWe are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
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Medical Device Regulatory Lead
3 weeks ago
New Delhi, India ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Leadwith4–6 years of proven hands-on experiencein medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities includingUS FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other global...
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Project Manager
3 days ago
Gurugram, India Infosys Full timeJob Description PMP Certification Project Management in Medical Devices - Project Management/Product Life Cycle Management of medical device products with agreed scope/budget/schedule with high quality deliverables. - Ensuring customer satisfaction by ensuring timely & high-quality deliveries. - Project/Program Management: Manages all phases of the project...
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▷ Immediate Start! Project Manager
3 days ago
Pune, India Infosys Full timeJob Description PMP Certification Project Management in Medical Devices Project Management/Product Life Cycle Management of medical device products with agreed scope/budget/schedule with high quality deliverables. - Ensuring customer satisfaction by ensuring timely & high-quality deliveries. - Project/Program Management: Manages all phases of the project...
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Medical Device Regulatory Lead
4 weeks ago
Hyderabad, Telangana, India, Telangana ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
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3 Days Left: Area Sales Manager
1 week ago
Delhi, India Fanem medical device Full timeJob description - Position Title Area Sales Manager -Delhi- Department Sales Marketing- Location Should be based in Delhi need to handle North Region- Reporting To National Sales Head Key Responsibilities - Drive sales of medical devices within the assigned territory to meet or exceed targets- Build and maintain strong relationships with hospitals clinics...
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senior regulatory affairs Executive
2 weeks ago
Delhi, Delhi, India LegalRaasta Technologies Pvt Ltd Full time ₹ 4,20,000 - ₹ 5,40,000 per yearWe are seeking a Senior Regulatory Affairs Executive with strong expertise in medical devices. The role involves handling end-to-end regulatory compliance, preparing and submitting dossiers, coordinating with CDSCO, managing product approvals, and ensuring adherence to medical device regulations. Candidate should have good knowledge of MDR, BIS, ISO 13485,...
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Senior Microbiology Trainer – Medical Devices
3 weeks ago
Haryana, India, India Tek Support Part timeJob Title: Senior Microbiology Trainer – Medical DevicesLocation: RemoteJob Type: Part-timeJob Summary:We are seeking an experienced Microbiologist with over 10 years of hands-on expertise in microbiology, sterilization, and quality assurance in the medical devices industry. The ideal candidate will design, develop, and deliver training programs to enhance...
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Head- Regulatory Affairs
3 weeks ago
Bengaluru, India Siemens Healthineers Full timeJob Description The Head of Regulatory Affairs will lead the regulatory function for Healthineers, Zone India, ensuring compliance with national and international regulations while supporting the company's strategic objectives. This role requires an experienced leader who can navigate the dynamic regulatory environment, advocate for the company's interests,...
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Regulatory/Quality Assurance
1 week ago
India Merlin MD Pte Ltd Full timeTips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). #...
