Regulatory Affairs Specialist For Medical Devices
4 days ago
We are HiringRegulatory Affairs Specialist For Medical Devices(Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA. 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Design & Development and Risk Management Files as per EU MDR. 5. Have Knowledge About QMS (Quality Management Systems). 6. Reporting To Regulatory Authorities. 7. Conducting Internal Quality Audits. 8. Have Knowledge of European CE (MDD & MDR). 9. Have Knowledge of USFDA 510K. Skill: 1. Documentation Handling. 2. Written & Verbal Communicate Skill. 3. Have Good Knowledge Of Computer And MS Office. Education Qualification of Candidate: B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science Discipline with Training in Medical Devices in Regulatory Affairs. Experience: Medical Devices: 3-5 years (Required) Salary Criteria: ₹30,000.00 - ₹80,000.00 per month - Depends on Interview Benefits: Leave encashment Provident Fund Yearly bonus
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Senior Compliance
4 weeks ago
New Delhi, India Hemant Surgical Industries Limited Full timeJob Title: Senior Compliance & Regulatory Affairs Specialist (Medical Devices)Location: MumbaiDepartment: Regulatory Affairs / Quality AssuranceExperience Required: 7–12+ yearsIndustry: Medical Devices / Healthcare / Pharma______________Job Summary:The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities related to BIS...
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Regulatory Affairs Specialist
4 weeks ago
New Delhi, India vueverse. Full timeRole Overview:Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities:- Prepare and submit regulatory dossiers for product approvals and renewals. - Develop and maintain Technical Files, DMR, and DHF. - Ensure compliance with...
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Regulatory Affairs Specialist
4 weeks ago
New Delhi, India vueverse. Full timeRole Overview:Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities:- Prepare and compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.). - Ensure compliance with ISO 13485, EU MDR...
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Regulatory Affairs Specialist
4 weeks ago
New Delhi, India NexorTest Technologies Full timeLocation: Bengaluru / HybridExperience: 5 - 8 yearsOverall Package: 8 - 10 LPARole Summary:The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working cross-functionally with...
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Medical Device Regulatory Affairs Consultant
1 week ago
new delhi, India beBeeMedicalDevice Full timeRegulatory Affairs SpecialistAs a key member of our team, you will be responsible for ensuring compliance with local and international medical device regulatory requirements.The role involves preparing and submitting regulatory documentation, maintaining quality system standards, and liaising with regulatory authorities to monitor updates to...
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Regulatory Affairs Specialist
3 weeks ago
New Delhi, India vueverse. Full timeRole Overview: Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities: Prepare and compileregulatory submissions(e.g., Device Master File, Technical File, 510(k), CE marking, etc.). Ensure compliance withISO 13485, EU MDR...
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Regulatory Affairs Specialist
1 week ago
New Delhi, India vueverse. Full timeRole Overview: Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities: Prepare and compileregulatory submissions(e.g., Device Master File, Technical File, 510(k), CE marking, etc.). Ensure compliance withISO 13485, EU MDR...
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Medical Device Regulatory Affairs Manager
2 weeks ago
New Delhi, India ELT Corporate Private Limited Full timeCompany DescriptionELT Corporate Private Limited is an Indian consulting company specializing in regulatory, legal, compliance, business, management, scientific, and technical services.Job Location:- Sector-3, Rohini, Near Rohini West Metro Station, DelhiRole DescriptionThis is a full-time, on-site role based in Delhi for a Medical Device Regulatory Affairs...
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Medical Device Regulatory Affairs Manager
2 weeks ago
New Delhi, India ELT Corporate Private Limited Full timeCompany Description ELT Corporate Private Limited is an Indian consulting company specializing in regulatory, legal, compliance, business, management, scientific, and technical services.Job Location:- Sector-3, Rohini, Near Rohini West Metro Station, Delhi Role Description This is a full-time, on-site role based in Delhi for a Medical Device Regulatory...
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Medical Device Regulatory Affairs Manager
2 weeks ago
New Delhi, India ELT Corporate Private Limited Full timeCompany DescriptionELT Corporate Private Limited is an Indian consulting company specializing in regulatory, legal, compliance, business, management, scientific, and technical services.Job Location:- Sector-3, Rohini, Near Rohini West Metro Station, DelhiRole DescriptionThis is a full-time, on-site role based in Delhi for a Medical Device Regulatory Affairs...
