- Actalent (Fresno, CA)
- …formulations, and labels and ensure compliance with corporate and FDA regulations. Complete technical document requests (statements to include specifications, ... and approve healthcare/nutrition product claims to ensure compliance with FDA , FTC, and other applicable regulations. Substantiate claims with...to act as a back up to the Regulatory Manager as needed. Performs other related and assigned duties… more
- Terumo Medical Corporation (Elkton, MD)
- …QS standards and federal regulations. (combine bullet 1 here) 14. Assist the Manager , Product Complaints with tasks such as FDA correspondence, occasional ... to US and global health authorities (GHA) such as FDA , HC, MHRA, etc. The Adverse Event Reporting Team...12. Assist with third party/regulatory audits (Customer, Notified Body, FDA ) 13. Monitor and remain current with internal company… more
- University of Pennsylvania (Philadelphia, PA)
- …and research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop solutions. Implement ... + Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the...the conduct of study audits by sponsors, CRO's, the FDA and other entities as required. + Participate in… more
- WuXi AppTec (Middletown, DE)
- …of User Requirements Specifications. + Ensuring compliance with regulatory requirements ( FDA , EMA, cGMP), quality standards, and safety regulations. + Conducting ... drawings, and functional specifications. + Thorough understanding of cGMP and FDA requirements + Strong communication and documentation skills + Proven project… more
- Covenant Health Inc. (Knoxville, TN)
- …from radiologists/physicians/surgeons, other health care professionals as well as ACR / FDA /other. Initiates and maintains Breast Center Program development . + ... on room renovation/construction and timeline to completion of installation. Assisting manager with Breast Center capital budget, operating budget and productivity +… more
- Bristol Myers Squibb (Princeton, NJ)
- …Ensure readiness for IND/IDE/PMA/510(k) touchpoints in partnership with Regulatory/QA. + Embed FDA QMSR/21 CFR 820, 21 CFR 11, EU IVDR, ISO13485, CLIA/CAP throughout ... as IHC, NGS, PCR, and flow cytometry, working under FDA QSMR (21 CFR Part 820), 21 CFR Part...+ US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to… more
- North Coast Seafoods (Boston, MA)
- …Boston. This role serves as the bridge between the Maintenance & Facilities Manager and the Maintenance Technicians, ensuring that all equipment and systems operate ... the maintenance team. This position reports to the Maintenance & Facilities Manager . Duties & Responsibilities + Lead and Supervise: Direct, mentor, and support… more
- Dana-Farber Cancer Institute (Boston, MA)
- …works under the direction of the Breast Oncology Principal Investigator(s), Regulatory Operations Manager , Clinical Research Manager and / or directly for the ... Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …a **maker of possible** with us. **Position Summary** The Senior Manager of EMI (Electromechanical Instrumentation) Quality Sustaining Engineering reports to the ... EMI plant locations will report directly to the Senior Manager and are under their authority for performance reviews,...evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface with… more
- ThermoFisher Scientific (Lenexa, KS)
- …and optimize lab operations. The supervisor will ensure compliance with FDA regulations, Good Manufacturing Practices, and other relevant guidelines. Key ... Ensure all duties are performed in accordance with Standard Operating Procedures, FDA regulations, and Good Manufacturing Practices. + Lead QC team, including… more