- Actalent (Northbrook, IL)
- …Operations leadership experience. + 10+ years of relevant experience in an FDA regulated industry and/or ISO certified organization. + High proficiency in ... more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …with transitioning diagnostic assays from research use to assay production or FDA pre-EUA approval; to include but not limited to, inclusivity, exclusivity, limits ... 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
- System One (New Haven, CT)
- …phase molecular imaging studies. Additionally, if qualified, the writer will support FDA Investigational New Drug (IND) document development (Module 2). The role ... more
- Actalent (Phoenix, AZ)
- …ensuring compliance with study protocols, Good Clinical Practice (GCP), and FDA regulations. You will be responsible for administering medications, performing ... more
- J&J Family of Companies (Santa Clara, CA)
- …for the treatment of calcified plaque. **Position Overview** In compliance with FDA , European MDD/MDR & ISO regulations, the Senior Quality Compliance Specialist ... more
- Boehringer Ingelheim (Hartford, CT)
- …System. + Performs all Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. + ... more
- Eurofins (Boston, MA)
- …and Quality Compliance: Support for compliance with regulatory requirements, including US FDA 510(k), De Novo, PMA, and Breakthrough Device submissions. + Safety and ... more
- Kelly Services (Rochester, NY)
- …compliance with design control requirements of company quality management system, ISO, FDA , and other regulatory agencies. Additionally, this role has oversight of ... more
- Abbott (Plano, TX)
- …report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within required timeframes. Prepares ... more
- Actalent (Phoenix, AZ)
- …Principal Investigator and in compliance with study protocols, GCP, and FDA regulations. Administer prescribed study and concomitant medications. Perform phlebotomy ... more
- Caris Life Sciences (Phoenix, AZ)
- …+ Knowledge of regulations pertaining to, or experience working in, clinical/CLIA/CAP/LDT and/or diagnostic/ FDA /IVD labs is a plus. + Knowledge of ISO 13485 and ISO ... more
- J&J Family of Companies (Raritan, NJ)
- …& Johnson and Legend Biotech. + Support the Raritan site readiness for FDA and health authority audits, as necessary **Qualifications** **Education:** + A minimum of ... more
- BD (Becton, Dickinson and Company) (Zelienople, PA)
- …the quality team to implement quality systems in compliance with FDA regulations and internal policies/procedures; drive continuous improvement projects focused on ... more
- Sanofi Group (Morristown, NJ)
- …and are organized in a manner to facilitate agency review. + Leads FDA interactions with cross-functional team support on both strategic and tactical product issues ... more
- BioBridge Global (San Antonio, TX)
- …advanced therapies. Leveraging its showcase facility designed to be compliant with FDA , EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on ... more
- Abbott (Des Plaines, IL)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... more