Regulatory Operations Assistant Ii

**Job Overview**: Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable. **Summary of Responsibilities**: - These statements are intended to describe the general nature of the job and are not intended to be an...

Job TitleRegulatory Affairs SpecialistJob DescriptionJob title:Regulatory Affairs SpecialistYour role:Be recognized as a key talent in International Regulatory filings and procedures.Be considered a key regulatory point person in Centralization of Regulatory Operations and enable the regulatory compliance in Markets where Philips products are...

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 Regulatory Reporting team, you are responsible for the timely and accurate preparation,...

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...

Step into the role of Credit Risk Regulatory at Barclays where we are committed to pushing boundaries. You will be involved in developing the technical solutions for a business area that has true customer and colleague impact. Your contribution to architectural decisions will change their banking and working lives for the better through technical designs...

Job TitleRegulatory Affairs Operations SpecialistJob DescriptionJob title:Regulatory Affairs Operations SpecialistYour role:Assisting, supporting, coordinating and preparing regulatory submissions for product licensing to ensure accuracy and expedite approval processes and identifies, defines and addresses problems that are not immediately evident but...

Capgemini is looking for a skilled Business Analyst specializing in General Insurance Regulatory, Finance and Accounting for a Leading Global Insurance Carrier. We are seeking a highly skilled and detail-oriented Business Analyst  with deep expertise in insurance finance, regulatory compliance, and accounting standards . This role will support strategic...

**Description** Regulatory Associate Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...

Job Overview:Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the...

**Key Interfaces** - **Regulatory Bodies**: Support communication and compliance coordination. - **Suppliers**: Assist in monitoring supplier performance and compliance. - **Internal Teams**: Collaborate with departments to implement food safety practices and resolve compliance issues. **Strategic & Planning** - Assist in developing and executing compliance...