Role: Senior Regulatory Affairs Specialist. Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product re...
The Regulatory Affairs Lead will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents, and overseeing the development of generics including Risk Evaluation and Mitigation Strategies (REMS) programs. Our cl...
Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, sup...
Medical Device Regulatory Affairs</li> <li class="MsoNoSpacing">Experience with <b>IVD Devices in Regulatory Affairs</b></li> <li class="MsoNoSpacing">Experience <b>with US 510(k) submission</b> in the last years</li> </ul&...
Anticipate regulatory obstacles and emerging issues throughout the product submission cycle and develop solutions with other members of regulatory and related teams</font></p> <p style="text-align:start; text-indent:0px; -webkit-text-stroke-width:0px; margin-left:48px">&l...
Job Title: Senior Regulatory Affairs Specialist</b></p> <p style="margin-bottom:11px"><b>Location:</b> Princeton, NJ 08540<br /> <b>Duration:</b> 12 Months<br /> </p> <p style="margin-bottom:11px"><b>Role Ove...
The qualified individual will be responsible for managing assigned tasks as part of the DEA Compliance Group as they relate to the Drug Enforcement Administration (DEA), the New Jersey Department of Health and the State of New Jersey Controlled Dangerous Substances (CDS), as well as ensure complianc...
Serve as project manager, lead engineer, and/or lead stormwater technical liaison with client on project efforts, including capital projects, new construction, retrofit and flood hardening projects for public and private sector entities. Kleinfelder is seeking an experienced Stormwater & Climate...
The Senior Analyst, Governance, Risk, and Compliance will be a key individual contributor in our Governance, Risk, and Compliance team. The team member will play a key role in maintaining our PCI compliance program, partnering with process owners, external auditors, and other stakeholders in order t...
Our client, a major Investment Bank, is seeking an experienced and highly skilled Project/Program Manager to join their team. Lead and manage complex projects and programs within the banking sector, focusing on innovation and efficiency. Work closely with technical teams, including architects, to en...
Engages in activities to provide support to the Compliance and Operational Risk teams in order to provide independent compliance and operational risk oversight of Global Compliance and Operational Risk performance and any related third party/vendor relationships in alignment with the Global Complian...
Engages in activities to provide support to the Compliance and Operational Risk teams in order to provide independent compliance and operational risk oversight of Front Line Unit or Control Function performance and any related third party/vendor relationships in alignment with the Global Compliance ...
Senior Regulatory Affairs Specialist. Collaborate with multiple business units to develop, update, and enhance regulatory affairs processes. Assist in strategy implementation and operations for regulatory affairs, including product registration submissions, progress reports, and amendments. Update a...
Global Regulatory Affairs Operation Sr. This position belongs to Global regulatory affairs department, serving the global Market which encompasses China US, EU, AUS and others. This role requires a detail-oriented professional who can oversee all regulatory affairs and quality assurance activities, ...
Regulatory Affairs AD/Director – Labeling. This person will oversee the US Regulatory Labeling activities and processes for regulatory submissions and product maintenance. The RA AD/Director will be responsible for building the team and then leading and managing its growth and development. ...
As a Technical Business Analyst, you will play a key role in the delivery of business requirements. Strong experience working with Trade Surveillance, Compliance, Regulatory Reporting. Work closely with the Compliance Stakeholders to ensure functional / Technical requirements are clearly specified. ...
The Compliance Data Analyst I will report to the GRC Senior Compliance Associate, and assist with ongoing data remediation, data quality checks, license verification from respective state boards to ensure federal, state and EU disclosure reports are reported timely and accurately on behalf of OAPI a...
Include: Manage Project Scope, Timeline and Budget/ Expenses; obtain and align resources to key project roles; establish clearly defined responsibilities and accountabilities; oversight/ Manage/ Lead project execution, integration and implementation Manager, Program Manager, Project Manager, Program...
The Compliance Data Analyst I will report to the GRC Senior Compliance Associate, and assist with ongoing data remediation, data quality checks, license verification from respective state boards to ensure federal, state and EU disclosure reports are reported timely and accurately on behalf of OAPI a...
Job Title:</b> Senior Regulatory Affairs Specialist<br /> <b>Location:</b> Princeton, NJ</p> </div> <div>(Onsite, Monday-Friday, 8:30 AM - 5:00 PM) </div> <div> <div> <div> <div> <div> <div> <div> <p><...
Minimum of 3 years of business experience, with 2 years in HCC or a compliance-related area: monitoring, testing, auditing, finance, compliance, regulatory, law, or a related field is required. Experience in Healthcare Compliance transparency reporting or financial data analysis is preferred. Prefer...
Manager/Associate Director, Regulatory Affairs Strategist. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development...
This person will provide project, program, and resource mgmt. Prepares program/project documentation such as executive presentations, reports, etc. ...
Regulatory Affairs Labeling Associate Level – I is needed to support Client' business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices. Applying strategic thinking, pharmaceutical educational knowle...
The Senior Manager Regulatory Affairs will play a critical role within Philips’ Clinical Informatics organization by leading regulatory projects for Philips’ Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the l...