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 ...
Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Manage and maintain regulatory databases and technical files. Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency req...
Principal Regulatory Affairs Specialist - Endoscopy. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and subm...
Responsibilities for preparation and submission of global regulatory applications, as well as maintenance of internal regulatory file documentation. Come join a growing, global division and become a member of a large and experienced regulatory team!. Acting as company representative, developing and ...
Principal Regulatory Affairs Specialist – Endoscopy. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and subm...
Principal Regulatory Affairs Specialist - Endoscopy. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and subm...
The Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global regulatory approvals to allow IPG to market its state of the art devices worldwide. Senior Regulatory Affairs Specialist #24-150 | Posted 07/24/2024 Marlborough, Massachusetts Ap...
Principal Regulatory Affairs Specialist - Endoscopy. This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and subm...
We are seeking a Regulatory Affairs Specialist to assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations. Develop and implement regulatory strategies for new and existing products. Suppor...
We have a robust pro Regulatory Affairs, Regulatory, Specialist, Principal, Product Development, Support, Business Services. ...
The Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs to obtain and maintain global regulatory approvals to allow IPG to market its state of the art devices worldwide. The ideal candidate is a diligent, hardworking individual with 2 to 5 years of regulatory expe...
We are seeking a Regulatory Affairs Specialist to assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations. Develop and implement regulatory strategies for new and existing products. Suppor...
Our client is currently seeking a Senior Regulatory Compliance Specialist. Monitor international standards and guide regulatory testing requirements. Assist with risk analysis and regulatory submissions. ...
This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufa...
We are seeking a Regulatory Affairs Specialist to assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations. Develop and implement regulatory strategies for new and existing products. Suppor...
Responsibilities for preparation and submission of global regulatory applications, as well as maintenance of internal regulatory file documentation. Come join a growing, global division and become a member of a large and experienced regulatory team! Learn more about our Urology division here: https:...
Principal Regulatory Affairs Specialist – Endoscopy . This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. Responsible for preparation and sub...
Tracks and reports on status of all project deliverables per the approved project schedule. Plans and executes one or more simultaneous project(s) from initiation through delivery. Organizes cross-functional activities, ensuring completion of the project while adhering to budget, scope and schedule ...
We are seeking an experienced leader with proven management and regulatory expertise s related to. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, field training materials, and ma...
Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA/IND/CTA/IMPD submissions materials. Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure re...
Quality Assurance Specialist Contractor. We’re looking for a motivated, experienced, purpose driven Quality Assurance Specialist Contractor to plan, coordinate, and execute a critical project to support compliance with all regulatory requirements. As part of our Quality Assurance team, you’ll be a v...
Oversee multiple projects simultaneously to meet regulatory deadlines . UST compliance or project management experience. ...
Responsible for integrating and applying knowledge of global regulations governing radiopharmaceutical drug development supporting the Company's preclinical/clinical development/commercial programs, including, developing regulatory strategy for all phases of drug development in order to progress reg...
Support projects through budgeting and permitting processes, including working with estimators to prepare construction and project costs, leading the project through permitting agencies and committees, and assisting the client in acquiring funding through public hearings and meetings. Weston and Sam...
We are seeking an experienced leader with proven management and regulatory expertise s related to advertising/promotional materials and labeling. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness c...