Regulatory Analyst
14 hours ago
Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745).
Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers.
Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle.
Assess the regulatory impact of product and process changes and ensure proper documentation and notification.
Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings.
Review and approve product labeling, IFUs, and promotional materials for compliance with US and EU regulations.
Ensure compliance with Unique Device Identification (UDI) requirements and support EUDAMED submissions.
Provide regulatory oversight for post-market surveillance, vigilance reporting, and adverse event investigations.
Liaise with regulatory authorities including FDA and Notified Bodies, managing communications and submissions.
Mentor junior regulatory team members and provide training on evolving regulatory requirements and best practices.
4+ years of experience, specifically focused on Medical Devices in the US and EU markets
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Regulatory Affairs Analyst
2 weeks ago
Pune, Maharashtra, India Varex Imaging Corporation Full time ₹ 4,00,000 - ₹ 12,00,000 per yearTo apply to a Varex Imaging position, please create an account and sign-in.CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.SummaryVarex Imaging Regulatory Affairs Analyst participates in the compliance of medical and industrial x-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional...
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Regulatory Operations Analyst
2 days ago
Pune, Maharashtra, India Deutsche Bank Full time ₹ 6,00,000 - ₹ 18,00,000 per yearAbout The Role : Job TitleRegulatory Operations Analyst LocationPune, India Role Description As part of the COO function, the Global Reporting & Performance Measurement department is responsible for the provision of client-specific and regulatory reports for the entire DWS Active, Passive & Alternatives business area.- As Operation Analyst in the...
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Data Analyst
6 days ago
Pune, Maharashtra, India EXL Service Full time ₹ 6,00,000 - ₹ 18,00,000 per yearGCP Data Analyst Now Hiring: GCP Data Analyst (Hybrid) Employment Type: Full-Time Experience: 5+ yrs Role Overview: We are looking for experienced Analysts (not Data Engineers) with strong expertise in Python and Google Cloud Platform (GCP), specifically BigQuery, to support critical analytics initiatives in the Banking domain. The ideal...
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Business Analyst
2 weeks ago
Pune, Maharashtra, India Ishan Technologies Full time ₹ 6,00,000 - ₹ 18,00,000 per yearJob Title: Business Analyst - Brokerage SME (BFSI)Job Summary:The Business Analyst with Brokerage SME expertise will act as a crucial link between business stakeholders and IT teams to gather, analyze, and document requirements specifically for brokerage operations within the BFSI sector. This role involves deep understanding of brokerage processes,...
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Analyst
2 weeks ago
Pune, Maharashtra, India Poonawalla Fincorp Full time ₹ 5,00,000 - ₹ 8,00,000 per yearJob Title: Strategy and Analyst – CollectionsDepartment:Collections StrategyLocation:Pune – Head OfficeReporting To:Head – Collections StrategyRole Overview:The Strategy and Analyst – Collections is responsible for driving data-backed strategies to optimize collections performance across portfolios. This role involves deep analysis of customer...
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Sr Analyst
4 days ago
Pune, Maharashtra, India SS&C Full time ₹ 12,00,000 - ₹ 36,00,000 per yearAs a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale, and technology.Job...
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Settlement Processing Analyst
14 hours ago
Pune, Maharashtra, India Easebuzz Pvt Ltd Full time ₹ 4,32,000 - ₹ 6,48,000 per yearJob Summary:We are looking for a detail-oriented and organized Settlement Processing Analyst to joinour Operations team. This role is responsible for the accurate and timely settlement oftransactions across multiple banks and payment modes. The ideal candidate will possessstrong analytical skills, a good understanding of settlement systems, and a...
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Knowledge Management Analyst
2 days ago
Pune, Maharashtra, India Anervea Full time ₹ 8,00,000 - ₹ 12,00,000 per yearJob Title:Knowledge Management Analyst- Pharma & Healthcare AnalyticsLocation:PuneExperience:2-5 YearsType:Full-timeAbout is building the next-generation AI-powered intelligence stack for the pharmaceutical industry. Our platform empowers global pharma teams—across commercial, clinical, and medical functions—with real-time analytics, predictive...
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Chargeback Analyst
6 days ago
Pune, Maharashtra, India Indiconnect Full time ₹ 5,00,000 - ₹ 12,00,000 per yearJob Title: Chargeback AnalystDepartment:Risk & ComplianceLocation:[Kharadi, Pune]Experience Required:1–3 years (minimum 2 years preferred)Employment Type:Full-timeJob Summary:The Chargeback Analyst is responsible for managing and resolving chargeback cases raised by cardholders or issuing banks. The role involves investigating disputes, analyzing...
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AML Review Analyst
7 days ago
Pune, Maharashtra, India Blucognition Full time ₹ 5,00,000 - ₹ 12,00,000 per yearAML Review AnalystJob Title: AML ReviewLocation: Pune, MHDepartment: Fraud OperationsEmployment Type: Full-timeRole Summary:The AML & Financial Crime Analyst is responsible for protecting the organization against financial crime risks by ensuring rigorous customer due diligence, transaction monitoring, fraud investigation, and strict regulatory compliance....