A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices.Key ResponsibilitiesProvide regulatory strategic leadership for medical device products, including AI / ML-enabled devicesLead regulatory submission teams and guide cross-functional teams on regulatory decision-makingConduct regulatory training programs on relevant topics and review device labeling for complianceRequired QualificationsBachelor's degree in a technical or scientific field8+ years of experience in Regulatory Affairs submissions for medical devices and digital health productsExperience with FDA regulations and international standards for medical devicesTechnical proficiency in at least two relevant product categoriesAdvanced degree or regulatory certifications preferred
Senior Regulatory Affairs Specialist
A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices. ...
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist. Senior Regulatory Affairs Specialist. Masters degree in regulatory affairs may be considered in lieu of direct regulatory experience. Participate as the regulatory functional product team member for the organizations Transfusion Medicine regulatory team. ...
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist I to manage regulatory documentation and submissions. ...
Regulatory & Scientific Affairs Specialist
As a Regulatory & Scientific Affairs Specialist, you will provide tactical regulatory expertise to help bring Innovation and Renovation projects to the market through cross collaboration with Marketing, Purchasing, Quality, and R&D. Regulatory & Scientific Affairs Specialist. Serve as re...
Senior Counsel Product and Regulatory Affairs
A company is looking for a Senior Counsel, Product and Regulatory Affairs (Liquidity). ...
Regulatory Affairs Specialist (Hybrid)
Regulatory Affairs Specialist provides regulatory guidance, monitoring and administrative help to the Institutional Review Board, Institutional Animal Care and Use Committee and Data and Safety Monitoring Board and other people involved in the conduct of research at all Baylor Scott & White Health. ...
Sr. Regulatory Affairs Specialist
Maintain Regulatory Affairs product files to support compliance. Develop strategies for worldwide product registration with global regulatory agencies. Author and prepare regulatory submissions for new products and changes. Review significant regulatory issues with supervisors and resolve submission...
Regulatory & Scientific Affairs Specialist
As a Regulatory & Scientific Affairs Specialist, you will provide tactical regulatory expertise to help bring Innovation and Renovation projects to the market through cross collaboration with Marketing, Purchasing, Quality and R&D. Regulatory & Scientific Affairs Specialist. Serve as regulatory repr...
Regulatory Affairs Specialist
Regulatory Affairs Specialist Dallas, TX. Provide regulatory guidance to PI’s and Research Staff to support the successful submission of regulatory compliant materials that are approved by the IRB or IACUC as applicable. This includes development of presentation regarding regulatory issues, tip shee...
Regulatory Affairs Specialist Project Lead I
Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact Client R&D pipeline, regulatory strategy or product portfolio. Accountable for sup...