Senior Regulatory Affairs Specialist
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
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist responsible for managing regulatory activities related to the Lung Health product portfolio. ...
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. ...
Principal Regulatory Affairs Specialist
A company is looking for a Principal Regulatory Affairs Specialist, US Regulatory Policy. FDA regulatory requirements and policyRegulatory experience within the medical device industry or a regulatory agencyExperience in advocacy related to healthcare policy and regulationsStrong research and analyt...
Senior Regulatory Affairs Consultant - CMC Biologics
In this highly visible role, you will partner with a large, global pharmaceutical company and provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure client's products are deve...
Senior Director Regulatory Affairs
A company is looking for a Senior Director, Regulatory Chief of Staff. ...
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 & 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...
Sr. Regulatory Affairs Specialist
Maintain Regulatory Affairs product files to support compliance. Develop strategies for worldwide product registration with global regulatory agencies. Provide regulatory advice, preparing worldwide submissions, negotiating approvals, and assisting with license maintenance, including renewals and ma...
Regulatory Affairs Specialist
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Prepare responses to customer requests for information, such as product data, written regulatory affairs ...
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. ...