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...
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 and validates compliance reports and data submissions. ...
Dive into a new opportunity - Elmhurst YMCA is hiring a full-time Aquatics Program Manager who is experienced in creating high-quality, and safe programming for our members and program participants. Complimentary Family YMCA membership and an employee discount on select programs. Ability to meet phy...
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...
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...
As a Senior Regulatory and Labeling Specialist at our clients company, you will play a crucial role in ensuring that finished product labels meet the strict requirements of FDA Labeling Laws and 21 CFR Regulations. Regulatory Label Development and/or Regulatory Compliance preferred. Stay up-to-date ...
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...
Act as the Project Manager for all sizes of projects. Work alongside Project Manager(s), leading the technical delivery of project tasks. The successful candidate will be a motivated, growth-oriented professional with the ability to lead and grow the Midwest Water project teams from the concept, fin...
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...
Job Title: Senior Regulatory and Labeling Specialist. As a Senior Regulatory and Labeling Specialist at our clients company, you will play a crucial role in ensuring that finished product labels meet the strict requirements of FDA Labeling Laws and 21 CFR Regulations. A minimum of 5+ years of workin...
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 ...
Ability to develop and implement systems and business processes to organize and document regulatory compliance. Identification and resolution to regulatory issues. ...
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...
ASAR Digital is seeking a highly experienced Senior SAP Project Manager to lead a critical project starting in October. The ideal candidate will have a proven track record of managing complex SAP projects, particularly end-to-end implementations of S/4HANA, CRM, and SAP Commerce Cloud. Oversee proje...
Job Title: Quality Compliance Specialist III. The Product Surveillance Specialist is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for pipe-line products and to deliver appropriate support in-line products enable a sustainable existence on...
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...
To perform this job successfully, an individual must be able to perform each essential function satisfactorily.The requirements listed below are representative of the knowledge, skills, and abilities required.Reasonable accommodation may be made to enable qualified individuals with disabilities to p...
To perform this job successfully, an individual must be able to perform each essential function satisfactorily.The requirements listed below are representative of the knowledge, skills, and abilities required.Reasonable accommodation may be made to enable qualified individuals with disabilities to p...
Applies basic knowledge of compliance, business, analytical, and communication skills to support compliance programs and processes that promote compliant and ethical behavior, meet regulatory obligations, and prevent, detect, and mitigate compliance risks. This position will focus on compliance with...
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...
Security Risk and Compliance Analyst will operate within a divisional security team reporting to the Director of Information Security. Analyst will be responsible for risk assessment, reporting and audit of Customer facing applications supporting the Tax and Accounting (TAA) and Corporate Performanc...