This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
Regulatory Affairs Specialist, Medical Device. Handling the regulatory assignments with a good understanding of medical process standards ISO13485, ISO14971, IEC 62304, and IEC 62366. Regulatory strategy preparation. Regulatory assessment for the Electro-mechanical devices. ...
The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Regulatory Affairs team is responsible for obtaining and maintaining regulatory approvals for Certis Biologicals li...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position involves interpreting ...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
Title: Food Regulatory Affairs Analyst Location: Baltimore, MD - Hybrid 2-3 days a week on-site Schedule: M-F 8am-5pm Type: 6-month contract extendable with a potential for hire Pay: $20-25 per hour Start date: Immediate Overview: Savor the flavor of a unique opportunity within our client's Regulat...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
AlliedTravelCareers is working with CompHealth to find a qualified Pharmacist in Salisbury, Maryland, 21801!. Our pharmacy department is looking for an experienced clinical oncology pharmacist specialist to join our team in a full time capacity serving primarily in our state-of-the-art Cancer Center...
Three (3) years of experience in conducting quality assurance (form, content, grammar and requirement compliance) of systems and software processes, PCA, documentation, and verification audits required. ...
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
The Level 3 Quality Assurance Specialist shall possess the following capabilities:. We're searching for talented individuals who provide Quality Assurance support. Review and provide feedback to the Government on the documents and deliverables ensuring that quality assurance requirements adhere to t...
Global Trade Compliance Specialist. Global Trade Compliance Specialist. This position focuses on implementing international trade compliance activities into daily business operations, conducting compliance assessments, and working with a variety of internal stakeholders to ensure that the proper pro...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
Fairly and consistently reviews team interactions with both internal and external parti Quality Assurance, Assurance, Specialist, Customer Service, Remote, Healthcare, Business Services. The Quality Assurance Specialist I is responsible for examining and evaluating the accuracy of transactions in ac...
The Compliance Analyst will perform compliance based audits to determine if health care providers are adhering to applicable regulatory requirements. We have 45+ years of experience assisting our government clients with complex health care reimbursement and provider compliance issues, operate 20 off...
Provide technical recommendations for technical publication updates. Oral and written communication skills to prepare complete, logically arranged, and legally defensible technical documents. Ability to edit and proofread work of colleagues, especially of detailed technical documentation and reports...
As part of our team, you'll get to leverage your Technical Writing Skills (while continuing to learn and improve your skills alongside our subject matter experts), to perform comprehensive technical writing tasks within a team of Systems Engineers, Software Engineers, and Intel Analysts supporting D...
In addition to execution of direct consulting services, the Senior Project Manager will eventually manage and mentor a small team of Project Managers and Assistant Project Managers. The Senior Project Manager will be a part of the Green Building Division which consists of New Ecology’s Certification...
Project Managers may also be assigned to support aspects of larger projects by Senior Project Managers and/or Project Executives as needed. Project Managers are responsible for the construction of additions, alterations, and renovations at The Johns Hopkins Hospital, The Johns Hopkins School of Medi...
Global Trade Compliance Specialist. This position focuses on implementing international trade compliance activities into daily business operations, conducting compliance assessments, and working with a variety of internal stakeholders to ensure that the proper processes, procedures, and authorizatio...