Compile regulatory documents for FDA submission (eCTD experience preferred), including: tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulato...
Which includes: tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying awa...
Which includes: tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying awa...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Senior Regulatory Affairs Specialist. Master’s degree in regulatory affairs may be considered in lieu of direct regulatory experience. Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team. Work with Regulatory and CFT to improve eff...
Which includes: tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying awa...
Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews an...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. ...
The Compliance Specialist will coordinate research compliance activities at the University's lakeside campuses to ensure regulatory compliance in human subjects research and animal research. Compliance with the regulations requires administrative support of the chairperson of the Institutional Revie...
If the answers to these questions were yes; then this Director Quality Assurance and Regulatory Affairs opportunity with an outstanding Medical Device organisation in Illinois might be the change you need. Ensures compliance with regulatory standards and readiness for inspections. Independently revi...
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. May lead the Labeling Regulatory Strategy Team (LRST), and serv...
Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Assures that regulatory strategies defined with...
The Project Manager operates as a valuable contributor within our Project Management Teams and reports to the Senior Project Manager. The Project Manager owns the complete project(s) scope from start to finish and ensures they are completed on-time. Position: Signage Project Manager. We have immedia...
This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality...
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management. Provides regulatory support and guidance a...
The Associate, Regulatory Affairs Submission Management, manages low to medium-impact submission projects involving multiple cross-functional regulatory submission teams. Job Title: Associate Regulatory Affairs Submission Management. With input from the submission teams, this individual establishes ...
Are you ready to lead regulatory strategies that will have a global impact? Join my client as a Senior Manager in Regulatory Affairs, where youll be at the forefront of innovation in the medical device industry. Manage and mentor a team of regulatory affairs professionals. Lead and shape regulatory ...
By the end of the program, you'll be prepared to take on a managerial position at one of our new or existing locations. Willingness to relocate within 18 months to take on a Sales Manager/General Manager role. Our 12-18 month program offers an immersive experience designed to equip you with the skil...
The Senior Manager Regulatory Affairs is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications for Sysmex products. The Senior Manager position in Regulatory Affairs leads the regulatory strategy for new and modified Sysmex medi...
Knowledge of generally accepted project management best practices, frameworks, and methodologies across both traditional and Agile approaches is expected, as is experience managing geographically distributed project team members and other stakeholders. Collaborate with project team to identify activ...
As a Regulatory Affairs Manager for my client, you'll play a key part in shaping the future of innovative medical devices. Step into a role where your regulatory expertise will make a global impact. Drive forward the development and compliance of products at the cutting edge of technology, ensuring ...
Project Manager (Quality/Clinical/Regulatory Affairs). The Project Manager provides project leadership for high-visibility, highly complex compliance initiatives across multiple business units and functions around the globe. This leader works closely with the program manager and project teams to def...
The Senior Regulatory Specialist responsible for Canadian legislation identifies, collects, and interprets science-based reports, data, and regulations in order to prepare documents for government agencies, curate lists, and develop Environment, Health, Safety, and Transportation (EHS&T) informa...
The ‘Senior Project Manager’ will be a part of Gallagher Bassett’s Product Development team and work with global business and IT organizations to accomplish the following objectives:. Conduct regular project status meetings, report on project progress, and communicate updates to stakeholders and sen...
Ability to develop and implement systems and business processes to organize and document regulatory compliance. Identification and resolution to regulatory issues. ...