- University of Pennsylvania (Philadelphia, PA)
- …with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is ... more
- Fujifilm (College Station, TX)
- …in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments, OR; + Bachelor's Degree with 4+ years of direct ... more
- Post Holdings Inc. (Lakeville, MN)
- …compliance engagement and communications with Customs Brokers, freight forwarders, CBP, FDA and USDA regarding entries, requests for import information, and ... more
- Globus Medical, Inc. (Limerick, PA)
- …company policies and procedures. Lead and enforce regulatory compliance with US FDA , State, OSHA and international medical device regulations and ISO 13485 quality ... more
- Boehringer Ingelheim (Ridgefield, CT)
- …legal inquiries related to product labeling revision. + Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents, for example, SPL, MS ... more
- Hologic (Marlborough, MA)
- …inflow and processing of customer complaints and adverse event reports, ensuring compliance with FDA 21 CFR, ISO 13485, IVDR, and FD&C Act requirements. + Manage the ... more
- Compass Group, North America (Greer, SC)
- …is responsible for the development and maintenance of all QA programs, meeting FDA , customer, and Corporate requirements, ensuring the quality and safety of supplied ... more
- BeiGene (Hopewell, NJ)
- …of materials, intermediates, and finished products in accordance with FDA /EU regulations, applicable International Regulations, and BeiGene processes and procedures. ... more
- Houston Methodist (Houston, TX)
- …internal inspections and audits to ensure compliance with Federal Drug Administration ( FDA ) regulations and cGMP Core policies and procedures. + Assists with ... more
- UTMB Health (Galveston, TX)
- …Scientist II will be assigned as a Study Director, as defined by the US FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point ... more
- Katmai (Brilliant, OH)
- …monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. Responsibilities will also include ensuring ... more
- Abbott (Atlanta, GA)
- …You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational ... more
- Fujifilm (College Station, TX)
- …validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments, OR; + Bachelor of Science Degree in Computer ... more
- Highmark Health (Columbus, OH)
- …**JOB SUMMARY** This job works in a team oriented environment monitoring FDA -approvals, drug manufacturer pipelines, and assess drug utilization reports, in order to ... more
- Specialty Rx, Inc. (Columbus, OH)
- …requires a strong understanding of CGMP (Current Good Manufacturing Practices) and FDA regulations, as well as mechanical knowledge to operate and maintain packaging ... more
- Battelle Memorial Institute (West Jefferson, OH)
- …state and city rules and regulations, the Drug Enforcement Agency, and the FDA (GLP) requirements. + Assist with the inspections and renewals of accreditations and ... more
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …needed during a deviation in the process. + Represents the company during FDA inspections; provides information as necessary to FDA that establishes credibility ... more
- Actalent (St. Paul, MN)
- …Ensure qualification and validation processes comply with regulatory requirements (eg, FDA , OTC monographs) and internal quality standards. + Support quality ... more
- Biomat USA, Inc. (Fairless Hills, PA)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... more
- Actalent (Clifton, NJ)
- …product labels, and quality documentation adhere to industry regulations, including FDA , cGMP, and international guidelines. The ideal candidate will have experience ... more
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