Current jobs related to Regulatory Affairs Specialist - Bengaluru - NexorTest Technologies
-
regulatory affairs
3 days ago
bengaluru, India Randstad Full timeWhat do we offer you? Competitive salary and benefits packageRemote work opportunitiesProfessional development and growth opportunitiesCollaborative and supportive team environmentChance to make a significant impact on a global scaleWork-life balance Who are you?We are looking for a dedicated and experienced Regulatory Affairs Specialist to join our...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Delhi, NCR, Vellore, India Airvin Skills Full time ₹ 2,00,000 - ₹ 8,00,000 per yearEWe are looking for a passionate and detail-oriented Regulatory Affairs Specialist (Fresher) to join our life sciences and healthcare compliance team. The ideal candidate will be responsible for assisting in the preparation, review, and submission of regulatory documents and ensuring adherence to national and international standards for product approval and...
-
Regulatory Affairs Specialist
19 hours ago
Bengaluru, India Seven Consultancy Full timeJob Description - Develop and implement regulatory strategies to ensure compliance with applicable laws and industry regulations. - Prepare, review, and submit regulatory documents, including clinical trial applications, marketing authorizations, and periodic safety update reports. - Collaborate with cross-functional teams, including R&D, Quality Assurance,...
-
Regulatory Affairs Manager
2 weeks ago
Bengaluru, Karnataka, India Kumar Organic Products Full timeJob Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...
-
Regulatory Affairs Specialist
5 days ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
-
Regulatory Affairs Specialist
5 days ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
-
Regulatory Affairs Specialist
5 days ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
-
Regulatory Affairs Specialist
5 days ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
-
Regulatory Affairs Specialist
4 days ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
-
Regulatory Affairs Specialist
3 days ago
Bengaluru, India UsefulBI Corporation Full timeAbout UsefulBI:UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview:We are seeking a Regulatory Affairs Subject Matter Expert...
Regulatory Affairs Specialist
4 weeks ago
Location: Bengaluru / Hybrid Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role 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 design, quality, clinical, and manufacturing teams to ensure regulatory compliance throughout the product lifecycle and to maintain an effective Quality Management System (QMS) aligned with ISO 13485 and other applicable standards. Key Responsibilities: Prepare, review, and submit regulatory dossiers and applications to CDSCO , including: Manufacturing and import licenses, Test licenses, Device registration dossiers, Post-approval variations and renewals Prepare Technical Documentation and Design Dossiers as per EU, India requirements. Prepare US FDA submissions , including: 510(k) , PMA , De Novo , and Q-Submission documentation. Address queries, deficiencies, and audits of Notified Bodies, CDSCO, and FDA reviewers Support implementation and maintenance of ISO 13485:2016, 21 CFR Part 820 (QMSR), and MDSAP requirements. Assist in creation and control of SOPs, CAPA, internal audits, supplier audits, risk management, and document control. Participate in management reviews and regulatory audits . Ensure QMS integration with regulatory submissions (Device Master Record, Design History File). Qualifications & Required Skills: Bachelor’s or Master’s degree in Biomedical Engineering, Pharmacy, any Life Sciences, or its related field . 5 - 8 years of experience in Regulatory Affairs for medical devices. Hands-on experience and good understanding with: CDSCO submissions and India Medical Device Rules (IMDR 2017) . EU MDR Technical File (STED) / Annex II–III documentation. US FDA submissions 510(k)/PMA. ISO 13485, 21 CFR 820, and MDSAP QMS frameworks. Familiarity with risk management (ISO 14971) , software as a medical device (SaMD) , and clinical evaluation requirements . Strong understanding of labeling, vigilance, and post-market compliance. Excellent documentation, communication, and stakeholder management skills. Preferred / Desirable: Experience working with consulting firms or global OEMs . Exposure to IVD devices , C ombination products , or digital health/SaMD . Certification in Regulatory Affairs (RAC) or Quality (CQE, Lead Auditor) is an added advantage.
