- GE HealthCare (Waukesha, WI)
- …+ Define validation dataset requirements (size, demographics, sites) in compliance with regulatory guidance. + Acquire, clean, and document datasets for ... **Job Description Summary** The Product Regulatory Engineer - Lead Biostatistician is responsible for...- Lead Biostatistician is responsible for activities contributing to regulatory submissions for AI-driven medical software and devices within… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …systems needed for the function including and not limited to CREDO ( document management), PRISM ( regulatory information management system), Global Trackwise, ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Sumitomo Pharma (Little Rock, AR)
- … regulatory affairs activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review in order to ensure ... highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced in Oncology.… more
- Oracle (Nashville, TN)
- …remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company ... of conformance to, the requirements of government regulations and/or regulatory agencies. **Responsibilities** Performs evaluation of internal operations, controls,… more
- Jacobs (El Segundo, CA)
- …22 Engineering Report for the use of recycled water, which is a key regulatory document in California. * Training and Education: Design and deliver training ... projects, together. #omfs #ourjacobs #bia Essential Functions and Responsibilities: * Regulatory Compliance & Reporting: Coordinate with the client on all… more
- Oracle (Raleigh, NC)
- …remedy risks and deficiencies. + Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as ... of conformance to, the requirements of government regulations and/or regulatory agencies. **Responsibilities** + Performs evaluation of internal operations,… more
- Huntington National Bank (Chicago, IL)
- …and balance sheet commentary. + Support and further strengthen sustainable regulatory liquidity reporting program. + Develop, document , and maintain ... guidance and rule interpretations for liquidity-related US regulatory rules and reporting requirements. Key Duties: + Collaborate across multiple departments to meet… more
- Vanguard (Malvern, PA)
- …of new compliance standards. + Execute advisory and monitoring activities to assess regulatory posture, document , track, and drive the resolution of compliance ... ideal candidate is a proactive advisor who can integrate regulatory AI compliance considerations into the entire AI system...considerations into the entire AI system lifecycle - ensuring regulatory alignment and ethical standards in AI use cases.… more
- Dentsply Sirona (York, PA)
- …to determine regulatory reportability in alignment with global and regulatory requirements; document rationale clearly and escalate ambiguous cases as ... responsible for evaluating product complaints and post-market data to determine regulatory reporting requirements, ensuring timely and accurate submissions to global… more
- Caris Life Sciences (Phoenix, AZ)
- …Initiation Visit meeting and offer ongoing site support. + Liaison with study sites and regulatory document team to ensure regulatory documentation is up to ... Summary** A Clinical Research Coordinator -Biorepository provides operational and regulatory support for the Caris sponsored studies and collaborative...date. + Ensures proper regulatory , legal, and financial disclosure documentation are on file… more