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. ...
You will primarily assist in the preparation of regulatory submissions for AgNovos’ lead product to ensure compliance with regulatory requirements in the EU, US FDA, and regulatory bodies in other countries. Working with both internal teams and external consultants, you will provide overall regulato...
European Union Regulatory Affairs Medical Device Quality/Risk Management US Regulatory Affairs. You will primarily assist in the preparation of regulatory submissions for AgNovos’ lead product to ensure compliance with regulatory requirements in the EU, US FDA, and regulatory bodies in other countri...
Position Overview We are seeking a Senior Regulatory Affairs Specialist to lead the development of Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) for managing Data Safety Monitoring Boards (DSMBs) within an electronic DSMB management system. Career Opportunity Are you lo...
We are seeking a Senior Regulatory Affairs Specialist to lead the development of Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) for managing Data Safety Monitoring Boards (DSMBs) within an electronic DSMB management system. Are you looking for an opportunity to drive inn...
Regulatory Compliance Specialist . Maintains effective relationships with research staff, Principal Investigators, Institutional Review Board (IRB) regulatory personnel, SC2i consortium regulatory counterparts, and other key stakeholders to ensure the continued scientific and operational functioning...
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...
The Regulatory Affairs Specialist is a critical member of the Regulatory and Laboratory Compliance team of Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences, Bethesda, MD. The Regulatory Compliance Specialist wil...
Ensures that protocol and regulatory documents are maintained and are kept up to date. Maintains study compliance with established local, state, federal, and DoD regulations for human subjects' research with institutional regulatory direction from USUHS, WRNMMC and HJF. Maintains complete and accura...
The incumbent will serve as an inter-agency consultant on compliance-related matters. This person will review to ensure compliance of Davis Bacon certified payrolls and customer Reasonable Accommodation requests. Will manage and monitor compliance reporting, investigate, follow-up and follow through...
The Compliance Analyst role within the Housing Opportunities Commission of Montgomery County entails a comprehensive set of responsibilities critical to maintaining and enhancing the quality and compliance of our affordable housing operations. The Compliance Analyst is responsible for identifying an...
Key Responsibilities:Conduct general trade surveillance reviews focusing on sales practice exceptionsAnalyze exception report data for trends and assist with compliance-related inquiriesPerform ongoing monitoring of sales practices, operations, and trading functionsRequired Qualifications, Training,...
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 Leadership Development Program Manager to enhance their people-first culture and leadership capabilities. ...
Director, Regulatory Affairs, Immunology. A company is looking for a Director / Sr. ...
A company is looking for an R&D Regulatory Specialist to develop and implement regulatory strategies for products in the biotechnology and pharmaceutical industry. ...
A company is looking for a Technology Compliance Analyst to join their Information Security team. ...
Program Manager, Advocacy for a 12-month contract position. ...
A company is looking for an Assistant Project Manager to support the Industrial & Agriculture team with project processing and management. ...
A company is looking for a Senior Regulatory Compliance Specialist to assist with the implementation and maintenance of its Compliance Software Program. ...
Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
A company is looking for a Regulatory Compliance Specialist 4 to support and implement audit programs for cloud infrastructure. ...
A company is looking for a Higher Education and Research Program Manager. ...
A company is looking for a Senior Localization Technical Project Manager to oversee projects in the digital space. Python, SQL)Experience with project management tools such as Asana or Jira. ...
A company is looking for a Claims Legal and Regulatory Compliance Specialist responsible for overseeing operational risk and compliance activities. ...