Regulatory Affairs Specialist
13 hours ago
Location: Bengaluru / Hybrid Experience: 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 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 renewalsPrepare 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 reviewersSupport 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, Combination products, or digital health/SaMD.Certification in Regulatory Affairs (RAC) or Quality (CQE, Lead Auditor) is an added advantage.
-
Regulatory Affairs Specialist
1 week ago
bangalore, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
-
Regulatory Affairs Specialist
1 week ago
bangalore, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
-
Regulatory Affairs Specialist
18 hours ago
bangalore, India NexorTest Technologies Full timeLocation: 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...
-
Regulatory Affairs Specialist
20 hours ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:Drafting controlled correspondences, pre-development meetings and...
-
Regulatory Affairs Manager I
4 weeks ago
Bangalore, Karnataka, India AstraZeneca Full timeJob Title Regulatory Affairs Manager I Global Career Level D1 Introduction to role Are you ready to be part of a team that transforms drug development strategies into reality The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning coordination and execution of assigned...
-
Regulatory Affairs Executive
3 weeks ago
bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
-
Regulatory Affairs Executive
3 weeks ago
Bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
-
Regulatory Affairs Specialist –
7 days ago
bangalore, India vueverse. Full timeKey Responsibilities: Regulatory Submissions & Compliance Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others. Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5). Convert and prepare dossiers in...
-
Regulatory Affairs Specialist –
1 week ago
bangalore, India vueverse. Full timeKey Responsibilities:Regulatory Submissions & ComplianceAuthor, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Convert and prepare dossiers in...
-
Regulatory Affairs Manager
6 days ago
bangalore, India Biocon Biologics Full timeKey Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation...
