Regulatory & QA Executive (Medical Devices)
1 week ago
Location: Marol, MumbaiExperience:2–5 Years Role SummaryManage regulatory submissions and maintain the Quality Management System (QMS) to ensure products meetISO 13485standards and regulatory requirements (CDSCO, FDA, or MDR as applicable). Key ResponsibilitiesRegulatory Filings:Prepare and submit technical dossiers for device license approvals, renewals, and import/manufacturing licenses (e.g., MD-14/MD-15 for India). QMS Maintenance:Manage SOPs, Change Controls, and CAPAs in strict compliance withISO 13485:2016 . Risk Management:Assist in maintaining Risk Management Files in accordance withISO 14971 . Audits:Conduct internal quality audits and assist during external regulatory inspections (Notified Bodies/Drug Inspectors). Post-Market Surveillance (PMS):Track customer complaints and adverse events; prepare PMS reports. Labeling Compliance:Ensure IFUs (Instructions for Use) and packaging labels meet regulatory standards before release. RequirementsEducation:B.Tech (Biomedical), B.Sc. Clinical Research, or similar Core Knowledge:Strong grasp ofISO 13485(QMS) andISO 14971(Risk). Familiarity with Indian Medical Device Rules (IMDR 2017) or EU MDR is highly preferred. Skills:Technical documentation, root cause analysis, and proficiency in Excel/Word. Traits:Detail-oriented with a zero-error approach to compliance.
-
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...
-
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...
-
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...
-
Regulatory Affairs Specialist
5 days 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...
-
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...
-
Medical Device Regulatory Affairs Consultant
7 days 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...
-
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...
-
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...
-
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...
-
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...
