- J&J Family of Companies (Santa Clara, CA)
- …+ Support company goals and objectives, policies, and procedures, QSR, and FDA regulations. + Other duties as assigned. **Requirements** + Bachelor's degree and ... Quality System Certification is a plus + Experience with FDA /ISO Audits, NCR, and CAPA experience is a plus...and verbal communication skills + Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality… more
- Avera (Sioux Falls, SD)
- …Brief Overview** Specializes in collecting blood from donors in accordance with FDA guidelines, using both traditional as well as apheresis procedures, and assumes ... registration, interview and vital signs for prospective donors in accordance with FDA guidelines to establish eligibility for donation. + Performs donor whole blood… more
- Takeda Pharmaceuticals (Boston, MA)
- …as global and/or regional regulatory lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for all US FDA submissions ... + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus. + Experience… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …+ Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. + Equivalency: In lieu of an Associate's degree, ... minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment. + Requires an in depth understanding of pharmaceutical manufacturing… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …lifecycle + Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms ... Regulatory Subject Matter Expert: Provide expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms.… more
- Pentax Medical (Montvale, NJ)
- …and manufacture of Speech, Voice and Swallowing products. + Facilitate all FDA registration and listing related activities. + Manage interactions with US Customs ... + Three-five years' experience in Regulatory Affairs for a FDA regulated employer + Thorough understanding of domestic and...in working directly with health authorities is required (ie FDA ) + Strong ability to manage critical projects as… more
- US Tech Solutions (North Chicago, IL)
- …and maintain **complaint files,** in compliance with regulations established by the FDA and international regulatory bodies, and submit safety reports to the ... FDA and international Competent Authorities. + In addition will...experience** + Familiarity with Regulations pertaining to devices/510K (ie FDA , MHRA, etc.) * Flexibility in managing multiple tasks… more
- Chobani (New York, NY)
- …standards for food equipment sanitation, UL/ETL electrical safety requirements, and FDA food contact surface regulations Equipment Design and Analysis: Create ... materials for food contact applications including stainless steel grades, FDA -approved plastics, and corrosion-resistant components Testing and Validation: Execute… more
- Compass Group, North America (Oak Creek, WI)
- …(SQF)** systems. This hands-on operational role ensures compliance with USDA, FDA , FSMA, and customer requirements while protecting consumers, customers, and brand ... + Lead internal and external food safety audits (USDA, FDA , GFSI, third-party) + Respond to customer quality and...GFSI auditor certification required + Experience with USDA/FSIS and FDA regulatory standards + Proven success in audit readiness,… more
- Texas Health Resources (Fort Worth, TX)
- …checks, review, and update all QA books, review all standards (ACR/TDH/ FDA and JCAHO), distribute film badges, generate and distribute continuing education ... certificates. Responsible for annual inspection by TDH and FDA . Attend monthly departmental staff meetings. Responsible for completing quarterly QI report for QRMC.… more