Regulatory Affairs Specialist
2 weeks ago
Job DescriptionJob Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to SaturdayJob Summary: We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India, the US, and the EU. This role requires strong coordination skills and a proactive approach to support product registrations, audits, and technical submissions.Key Responsibilities: Conductgap analysisof existing regulatory and technical documentation. Prepare and maintain regulatory submissions including: Device Master Files Risk Management Files Design History Files Clinical Evaluation Reports Usability Reports Draft and update product labeling content such asInstructions for Use (IFUs) ,implant cards , anddeclarationsto meet global compliance requirements. Supportregulatory submissionsfor India (via CDSCO/SUGAM/NSWS), US (FDA), EU (CE marking under MDR), and other applicable markets. Coordinate with cross-functional teams includingPurchase, Accounts, Legal, Marketing , andR&Dto gather documentation and resolve queries. Assist in preparing and submitting responses foraudit-related queriesand regulatory inspections. Contribute to regulatory strategy fornew product developmentsand modifications. Stay updated with changes in regulatory requirements and industry trends through self-learning and structured training.Educational Qualifications: Bachelor’s or Master’s degree inPharmaceutical Sciences ,Engineering ,Biotechnology ,Microbiology , or a related life science field. Specialization inRegulatory AffairsorQuality Assurancepreferred.Experience: 1 to 4 yearsof industry experience in a Regulatory Affairs role, preferably in medical devices, pharmaceuticals, or life sciences. Hands-on experience with global and domestic regulatory submissions. Exposure to documentation systems and regulatory portals (CDSCO/SUGAM/NSWS) is essential. Experience or knowledge ofsoftware regulationsis an added advantage.Key Skills and Competencies: Strong knowledge of: Regulatory frameworksincluding ISO 13485, EU MDR, and 21 CFR Part 820 Risk management ,design controls , andpost-market surveillance Excellentdocumentation, analytical , andtechnical writing skills Proficient inMicrosoft Office Suiteand digital documentation platforms Strong interpersonal skills to collaborate with internal departments and external bodiesSoft Skills: Go-getter attitudewith the willingness to lead and take initiative HighEnglish proficiency– both verbal and written Strongorganizationalandtime managementskills Ability to work independently and as part of across-functional team. Fast learner with a proactive mindset for continuous development.Monday to Saturday working Company Website: https://www.laxmidentallimited.com/ https://www.illusiondentallab.com/ https://www.illusionaligners.com/
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Regulatory Affairs Specialist
4 weeks ago
New Delhi, India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
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Regulatory Affairs Specialist
1 week ago
New Delhi, India Illusion Dental Laboratory Full timeJob DescriptionJob Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to SaturdayJob Summary: We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure...
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New Delhi, India MJ Surgical Full timeWe 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...
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Quality and Regulatory Affairs Specialist
1 week ago
Delhi, NCR, Noida, India Saraca Solutions Full time ₹ 4,00,000 - ₹ 8,00,000 per yearWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist with expertise in regulatory compliance for medical devices across the EU, India, and the US.Clinical EvolutionMedical WritingTechnical Documentation
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New Delhi, India Danaher Full timeThis job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and...
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Regulatory Affairs Specialist
2 days ago
New Delhi, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing indata engineering, cloud transformations, and AI-powered analyticsfor Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview: We are seeking aRegulatory Affairs Subject Matter Expert...
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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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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 Manager
3 weeks ago
New Delhi, India Ixoreal Biomed Full timeAbout the Company : Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Executive
2 weeks ago
New Delhi, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
