- Praxair, Inc - a Linde Company (Fresno, CA)
- …- $112,200 yearly (commensurate with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations within ... Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure … more
- Globus Medical, Inc. (Methuen, MA)
- …technologies. + Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + ** Regulatory & Quality Compliance** + Ensure adherence ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Grifols Shared Services North America, Inc (Vista, CA)
- …FDA regulated environment; Project Management experience required + Thorough knowledge of FDA and international regulatory , quality and cGMP regulations + ... manufacturing and quality policies to assure the compliance with the FDA and/or EC, if applicable. And other applicable regulations guidelines and practices… more
- Unilever (Austin, TX)
- …such as the FDA and FTC. In addition to managing day-to-day quality and regulatory functions, this leadership role requires strategic oversight and close ... be part of it. **JOB SUMMARY** The Senior Director, Quality Assurance and Regulatory Affairs will lead...internal audits and support third-party, FDA , and regulatory inspections. + Generate and analyze quality … more
- WuXi AppTec (Middletown, DE)
- …preparation and maintenance of User Requirements Specifications. + Ensuring compliance with regulatory requirements ( FDA , EMA, cGMP), quality standards, and ... and powder packaging. + Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs. + Experience in… more
- University of Pennsylvania (Philadelphia, PA)
- …appropriate Sponsor Oversight. The Regulatory Affairs Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality reviews of all ... Regulatory Affairs Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality... FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for… more
- Actalent (Valencia, CA)
- Description The Quality Regulatory Affairs Specialist will be a key contributor to ensuring full compliance with regulatory standards while upholding the ... R&D and Quality teams to assess formulations and claims for regulatory compliance. + Collaborate with internal teams to facilitate certifications from … more
- Boehringer Ingelheim (Ridgefield, CT)
- …development experience/knowledge with a minimum of ten (10) years' experience in Regulatory Affairs, FDA , or equivalent experience in the regulated ... and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with...a minimum of eight (8) years of experience in Regulatory Affairs, FDA , or equivalent experience in… more
- Abbott (Alameda, CA)
- …people's lives. **The Opportunity** Lingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables initiative ... Europe, Gulf Countries, and Asia. Overseeing all aspects of quality and regulatory affairs, from design and...or connected health solutions. + Extensive knowledge of global regulatory requirements, including FDA regulations (eg, 21… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Coordinator works directly for the Clinical Trials Office to complete and oversee FDA regulatory requirements specific to vaccine research or other critical ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...regulatory compliance with all Food and Drug Administration ( FDA ), National Institutes of Health Office of Special Projects… more
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