We are looking for CRAs with at least 6 years monitoring experience and 3-4 years in Oncology . .
MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits). Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations. Maintains regular review of site regulatory binder and ensures proper storage, ...
Job: Sr. Principal Regulatory Policy Coordinator
Global Technical Services – Ada, MI
Reporting to the Global Director Regulatory Policy Influence, this individual will work to meet the challenges of an ever changing global regulatory environment, working with associations and industry organizations to influence regulations, identify issues, and leverage relationships to enhance corporate credibility and protect the Enterprise in the marketplace. This individual will develop proactive lobbying ...
The client is seeking a Formulations Chemist for its operation in Hartland, Wisconsin. They are a leading formulator, manufacturer and marketer of topical products targeting the massage therapy and spa professions.
The Formulations Chemist is responsible for formulating topical cosmetic products for the spa/massage markets. The role is primarily New Product Development, but also serves as the main technical point of contact supporting the manufacturing, regulatory, and ...
Role: Strategic planning and management for the execution of comprehensive programs related to regulatory clearances, controls, and the assurance of corporate compliance with applicable US and international medical device regulations and standards.
•Create strategy and perform oversight for global commercialization and post-market regulatory activities.
•Establish and implement regulatory policies and procedures.
•Supervision of global Regulatory Affairs professionals to ...
GF Health Products, Inc. (“GF”) is a nationally known manufacturer and distributor of medical devices and related products in the medical/surgical, homecare, long term care, and consumer markets. GF is committed to the provision of customer support for each and every one of our products.
Provides support and quality assistance to customers and sales representatives to assure their needs are satisfied.
ESSENTIAL DUTIES AND RESPONSIBILITIES
•Process and research ...
This position will act as a regulatory interface with both internal and external customers and prepare written correspondence in response to customer requests for regulatory information. The position will also prepare regulatory submissions as needed and assists the Regulatory Affairs Director in the day-to-day operation of the department.
▪ Prepare and submitting required documentation for pre-market notifications and approvals.
▪ Assist in the management of critical post ...
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