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...
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...
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 ...
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...
Regulatory Affairs Specialist (Level II or Senior Level). BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred. ...
Senior Regulatory Affairs Specialist. Responsible for managing product based regulatory activities of a medical device company that designs, manufactures, sells, and services medical imaging equipment. Manage preparation of regulatory documentation to facilitate the commercialization of new products...
The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Principal Regulatory Affairs Specialist – Surgical. The Principal Regulatory Affairs Spe...
The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Completes and submits all required Federal and State reports and acts as a liaison ...
Senior Regulatory Affairs Specialist. Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Serve as RA Repre...
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...
Actively participate in problem solving discussions and recommend solutions • Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies • Assist in the maintenance and improvement of regulatory SOPs • Interact and negoti...
Yield10 is searching for a Regulatory Affairs Specialist. The successful candidate will support regulatory activities at Yield10 Bioscience including drafting, securing, and submission of USDA-APHIS BRS permits and notifications for movement and release of regulated crop material, overseeing regulat...
Affairs, Marketed Products in Cambridge, MA to Assist the Global Regulatory Lead (GRL) and is accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissio. ...
Provide program level acquisition support to the Program Manager and Integrated Product Team Leads by helping guide successful program execution to maintain the acquisition battle rhythm and deliver warfighter capability. Provide support and solutions to program leadership to facilitate successful c...
Supply Chain & Materials Project Manager. Supply Chain & Materials Project Manager. ...
The Program Account Manager is responsible for the operations of group employee benefit captive programs managed by SRS. Assist in the evaluation of vendor partners for the programs and co-ordinate the smooth implementation of vendors to the program including coordinating informational sessions for ...
Pre-Construction Geotechnical Project Manager. Our client is seeking an experienced Pre-Construction Geotechnical Project Manager to join their estimating, sales, and management team in the New England area. A minimum of 3-5 years of management experience in Geotechnical Engineering and Project Mana...
Regulatory Affairs and Quality Assurance Manager. In this position you will: Manage and coordinate the regulatory affairs and quality assurance departments of the Company while reporting directly to the President. Cambridge Interventional is seeking a Manager of RA/QA. Prepare and submit device regu...
The APM is responsible for the overseeing, coordination, and timely completion of projects. ...
Project Manager/ Program Manager. Cultivate a technology ecosystem that meets the current and evolving needs of the MBA and Doctoral programs, such as joint degree programs and evolving student schedules. Program Manger SIS (Student Information System). This person will lead the Student Information ...
Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development p...
Project Management Courses or documented PM track record. ...
Transportation Compliance Specialist. Director of Transportation Compliance and is responsible for providing governance of all imports and exports for all of the Company's divisions administering cross-border moves of equipment, vehicles, specialty items, tools, electronics, waste, chemicals, etc. W...
We are seeking a skilled Commissioning Project Manager to join our team. Develop commissioning plans, procedures, and schedules in collaboration with project stakeholders. Provide technical support and guidance to project teams during the commissioning process. Participate in project meetings, revie...
As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Senior Manager/Associate Director, Regulatory Strategy. Your expertise and leadership will be in...