- Danaher Corporation (Sunnyvale, CA)
- …to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance. This position is part of the Quality department ... . + Participate in external audit management ( eg FDA , ISO, Danaher Corporate, foreign governments), in either a...and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic Regulation… more
- Fujifilm (Bothell, WA)
- …component selection, and grounding schemes. Previous experience working with FDA -regulated products is highly desired. **Company Overview** At FUJIFILM Sonosite, ... work, reliability, schedule, and cost to support the project manager , and delegation of tasks on one or more...develop electronic module qualification plans and reports. + ISO, FDA or other regulated industry training and experience are… more
- North Coast Seafoods (New Bedford, MA)
- …department's requirements are met. This position will report to a Production Manager . DUTIES AND RESPONSIBILITIES + Assist with managing the processing of products ... of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …Unit on implantable and absorbable devices. Under the mentorship of the Manager of Regulatory Affairs, the position will provide technical and administrative ... products. **Responsibilities:** + Assess necessity for reporting changes to FDA /Notified Body for proposed device modifications. Prepare robust reporting… more
- Integra LifeSciences (Plainsboro, NJ)
- …Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend first shift ... all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the… more
- Fujifilm (Lexington, MA)
- **Position Overview** This position is intended to report to the Senior Manager , R&D, and working under their supervision, the R&D Engineer supports New Product ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- ThermoFisher Scientific (Rockville, MD)
- …collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally required guidance. + Relies on experience and ... years of experience in clinical research coordination, with expertise in FDA -regulated trials. + Experience utilizing clinical trial management systems and databases… more
- Medtronic (Lafayette, CO)
- …lifecycle. + Ensure compliance with all relevant regulatory requirements, including FDA , ISO, and other international standards, and participate in regulatory audits ... technical field. Advanced degree preferred. + **Regulatory Knowledge:** In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards. +… more
- BeOne Medicines (Pennington, NJ)
- …and release of materials, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... the Chemistry laboratory. This position reports to the QC Manager and is located full time at the Hopewell,...Minimum of 4+ years of working experience in an FDA -regulated biotechnology, pharmaceutical company are required. + Familiar with… more
- Kuehne+Nagel (Plymouth, MI)
- …customs entry transactions. Additionaly perform any tasks which are assigned by the Manager or Supervisor that meets and supports the needs of the Customs Brokerage ... Customs & Border Protection; PGA's (Participating Governmental Agencies ie FDA , EPA, DOT, FCC, Fish and Wildlife ) **How...+ Accurate completion of all PSG data interfaces (ie FDA , EPA, DOT, FCC, Fish & Wildlife etc )… more