The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timeli...
This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strate...
The Associate Director, Regulatory Strategic Planning is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business...
The Associate Director, Regulatory Strategic Planning is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business...
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 ...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. ...
This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strate...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (-day Notice, Real-Time Reviews, -Day Supplements, Annual Reports).Review/approval of engi...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timeli...
Associate Regulatory Operations Manager in Northbrook, IL to prepare, submit, distribute, and archive routine regulatory agency submissions. ...
Duration: 1 yearEmployment Type: W-2 Overview:The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains su...
The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities. Leading Regulatory Affairs strategy end-to-end executio...
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...
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...
The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes. Regulatory Affairs Program Manag...
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...
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...
Manager, Regulatory Affairs - Labeling. Independently ensuring all project timelines and regulatory commitments are met for labeling at all stages of the product lifecycle, and with no disruptions to commercial availability of marketed products, driving measurable efficiencies and continuous improve...
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...
The Manager of Regulatory Affairs – Product Development and Post Approval serves as the primary regulatory interface with Partners and internal teams regarding Drug Product and Analytical method development and post-approval activities. Manager, Regulatory Affairs – Product Development a...
Embark on an exciting journey as a Project Manager in the dynamic Enclosures Division. Oversee and manage the entire project lifecycle, from initiation to successful completion, ensuring timely deliveries of enclosure units. Collaborate closely with sales, engineering, production, and customers to a...
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...
Regulatory Affairs Professional certification preferred. The Regulatory Affairs Associate is an exempt position that is paid semimonthly. Leads regulatory activities for medical device, over-the-counter, and prescription drug products. Compiles and prepares regulatory documents (summary technical do...
The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Provides regulatory support for diagnostic product development and commercia...
Global Regulatory Affairs Strategy roles (U. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Re...