
Regulatory Analyst
2 days ago
Job Description - 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 Operations Analyst
1 week ago
Pune, India Deutsche Bank Full timeJob Description Position Overview Job Title: Regulatory Operations Analyst Location: Pune / Bangalore, India Role Description We are seeking a highly motivated and detail-oriented Operations Analyst to join our Regulatory Reporting team. The role is to perform several key functions that support and control the business in complying with a number of...
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Regulatory Affairs Analyst
2 weeks ago
Pune, India Varex Imaging Corporation Full timeDescription Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform...
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Analyst - Regulatory Reporting
1 week ago
Chennai, India Barclays Full timeJob Description Join us as an Analyst - Regulatory Reporting at Barclays, where you'll spearhead the evolution of our digital landscape, driving innovation and excellence. You'll harness cutting-edge technology to revolutionize our digital offerings, ensuring unparalleled customer experiences. To Be Successful In This Role, You Should Have - Internal Control...
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Regulatory Operations Analyst
4 weeks ago
Pune, India Deutsche Bank Full timeAbout 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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Regulatory Analyst
4 weeks ago
Pune, India eClerx Full timeWe are hiring for Senior Analyst/Associate Process Manager (1-4.5 years) professionals who have relevant experience into Trade transaction and Regulatory Reporting. ** Experience in any of the following MiFiD/ SFTR/ EMIR/ DTCC/ Basel/ UnaVista/ Regis-TR would be an added advantage. Responsibilities- Stakeholder management across Front Office, Operations,...
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Regulatory Operations Analyst
7 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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Regulatory Analyst
5 days ago
Pune, Maharashtra, India Cyient Full time ₹ 15,00,000 - ₹ 25,00,000 per yearDevelop 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...
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Regulatory Operations Analyst
2 weeks ago
Pune, India Deutsche Bank Full timeDescription 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 Regulatory Reporting team, you are responsible for the timely and accurate preparation,...
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Regulatory Reporting
5 days ago
India CAPCO Full time**Job Title**:Business Analyst/Data Analyst/Data Modeller** **About Us** “Capco, a Wipro company, is a global technology and management consulting firm. Awarded with **Consultancy of the year in the**British Bank Award** and has been ranked **Top 100 Best Companies for Women in India 2022 by**Avtar & Seramount**. With our presence across 32 cities across...
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Regulatory Filtering Analyst
2 weeks ago
Bengaluru, India Deutsche Bank Full timeJob Description Position Overview Job Title:Regulatory Filtering Analyst Corporate Title: NCT Location: Bangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its...