IVD or medical device FDA registration.International Device Licensing and Registrations.FDA and other inspection agencies as needed....
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Collaborates with other functional work teams , Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of glob...
This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. Title: Regulatory Affairs Manager. The Regulatory Affairs Manager will be re...
Provides leadership to the Regulatory labeling team in the creation and maintenance of global product labeling components. Supply Chain, Operations, Commercial and Clinical, providing regulatory guidance to aid in the preparation and submission of global product labeling materials. Employs a current...
Under the general direction of the Director or designee, the Project Manager III bleads organization-wide large projects. The Project Manager III is responsible for initiating action on multiple projects in a matrix environment. Communicate project status, budget, costs, issues, and related informat...
Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/adverti...
This position of Project Manager, Capital Programs reports to the Associate Director of Capital Programs. The Capital Programs Department is responsible for the design and construction of all capital projects for Tufts University. At a project's inception this includes developing programmatic scope,...
Senior Manager of TPL Claims Programs- Hybrid. Develop and implement policy, procedure, and program tracking standards in regards to program monitoring and evaluation. The Benefit Coordination and Recovery (BCR) team is seeking a Senior Manager who will oversee department operations, contract manage...
Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships. Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on reg...
The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. Conceive of and Implement the Regulatory Strategy in ...
As part of a team-based approach to care, the Clinical Care Manager (CCM) provides, coordinates, and organizes evidence-based care management to Medical Assistant Treatment Program (MAT) patients. We are currently hiring a Clinical Care Manager – OBAT RN based in Framingham. Responsible for as...
Represents Regulatory Affairs at project team meetings. Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that ma...
Associate Director Level: Minimum of 7 years in the pharmaceutical industry, with at least 4 years dedicated to regulatory labeling. Develop and implement regulatory labelling strategies for new product labels and launches. Contribute to or lead strategic initiatives, ensuring compliance and alignme...
Project Managers (PMs) are vital to the successful completion of projects. They manage project information, ensure accuracy, quality, timeliness, and work with an on site construction manager to meet goals safely, within budget, and on schedule. PMs handle budgets, schedules, job costing, and overal...
Minimum of 10 years in the industry, with at least 8 years dedicated to regulatory affairs. Demonstrated ability to drive high-level regulatory strategy and navigate complex regulatory landscapes. The client is seeking a seasoned professional to lead their regulatory strategy for a late-phase oncolo...
Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standar...
The Program Manager's primary function will be to provide comprehensive knowledge of principles, policies, and practices of systems acquisition and program management. The Program Manager shall possess the knowledge of qualitative and quantitative techniques for gathering, analyzing, and measuring t...
The Social Compliance Manager will be responsible for communicating program requirements and expectations to TJX Associates, buying agents and vendors. Manages Social Compliance Senior and Social Compliance Specialist. At TJX, our philosophy towards social compliance mirrors our culture, and just as...
EPM are looking for two Quality Assurance Specialists with extensive experience in compliance responsibilities. The specialist in question will be expected to be On-Site 5 days a week, this would be a non-negotiable! The work would involve experience working with systems such as Trackwise, Veeva or ...
The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier audits as assigned, participates in customer and regula...
Work independently as a program lead, provide tactical oversight and continuity throughout the lifecycle of the assigned program and project(s). Benefits include Associate discount; 401(k) match; medical/dental/vision; HSA; health care FSA; life insurance; short/long-term disability; paid holidays/v...
Global Project Manager will manage large capital projects from project initiation through execution and closeout. The Project Manager will identify and develop the project requirements and then develop the project scope and plan to meet those requirements. Lead cross-functional teams, applying proje...
Support the lead regulatory strategy for late-phase oncology programs, ensuring alignment with global regulatory requirements. Minimum of 8 years of industry experience, with at least 4 years in regulatory affairs. Strong technical proficiency in regulatory affairs is crucial. The client is seeking ...
Assist the VP/Senior Compliance Officer and collaborates with Learning & Development department with the online compliance training program which includes identification and assignment of the online compliance courses, as well as administration, maintenance, and reporting of the system. Retail bank ...
Year College Degree/Bachelors in Business, Architecture, Engineering, Construction Management10+ years of project management experience for real estate development projectsTravel to project sites primarily located in Rhode Island while occasionally supporting projects in Massachusetts as the need ar...