A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products. CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required. ...
The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategies, and provide executive management with regulatory metrics/information. Anticipate regulatory obstacles an...
As the Senior Global Regulatory Affairs Specialist, you will be responsible for regulatory activities related to the development and implementation of global regulatory strategies to support the submission, filing, and registration of multiple indications (clinical applications or “apps”) in general...
The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information. Anticipate regulatory obstacles and ...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. ...
Assist Regulatory Management with product deviation reporting to the FDA. Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements. ...
The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information. Anticipate regulatory obstacles and ...
Leor Weinberger, director of the Gladstone-UCSF Center for Cell and Viral Circuitry, seeks a highly motivated Regulatory / Clinical Affairs Specialist to manage regulatory affairs, author and assemble IND applications, and help manage FIH studies on new antiviral gene therapeutic candidates. The pos...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
The Ambulatory Regulatory Compliance Specialist has a pivotal role within the organization and is responsible for ensuring adherence to regulatory standards across diverse areas. The Ambulatory Regulatory Compliance Specialist will play a crucial role in ensuring ongoing compliance with The Joint Co...
Under the guidance of the Campus Risk Manager, the ERM Analyst 3 will perform a broad range of tasks in connection with the review of insurance, indemnification and limitation of liability provisions in complex contractual agreements for compliance with Regents Standing Orders. The ERM Analyst 3 wil...
A company is looking for an R&D Regulatory Specialist to develop and implement regulatory strategies for products in the biotechnology and pharmaceutical industry. ...
Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
A company is looking for an SEO / Marketing Project Manager. ...
A company is looking for a Project Compliance Specialist. ...
Director, Regulatory Affairs, Immunology. A company is looking for a Director / Sr. ...
A company is looking for a Workforce Management Program Manager. ...
A company is looking for a Section 508 Compliance Specialist to ensure digital accessibility and compliance with federal standards. ...
A company is looking for a BPO Program Manager to implement business initiatives and drive efficiency with third-party BPO partners. ...
A company is looking for a Senior Medicare Communications Compliance Specialist to support regulatory requirements associated with Medicare materials and sales compliance. ...
A company is looking for a 340B Audit-Comp Analyst to assist with the coordination of the 340B Drug Pricing Program across its health system. ...
A company is looking for a Junior Project Manager to oversee the delivery of inspection services for offshore wind farms. ...
A company is looking for a Compliance and Data Analyst I to ensure regulatory adherence and support data analysis for compliance-related tasks. ...
A company is looking for a Capture Technical Program Manager for its Public Sector division. ...