- Olympus Corporation of the Americas (Westborough, MA)
- …of the OSTA HF team and as an Human Factors expert providing project support, mentoring and guidance in Human Factors and Usability Engineering processes, managing ... for the region. + Strategically plan OSTA Projects at times with project HF team member, determining required activities and level of effort, resourcing.… more
- Medtronic (Lafayette, CO)
- …existing products. + Effectively communicate findings, problems and solutions to project teams and stakeholders. + Collaborate and maintain excellent working ... IN THE ROLE:** + Knowledge of applicable AAMI, ISO, FDA and EN standards + BS / BA in...Agile and iterative development practices is a plus. + Project management skills including planning, estimation, tracking and communication… more
- Medtronic (Boston, MA)
- …+ Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts. + ... lifecycle. + Ensure compliance with all relevant regulatory requirements, including FDA , ISO, and other international standards, and participate in regulatory audits… more
- Stanford University (Stanford, CA)
- …the world of health care in the cancer arena. Reporting to the Clinical Research Manager (CRM), the CRC2 will be conversant in the goals, mission, and priorities of ... monitor data collection. Extract, analyze, and interpret data. + Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team… 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
- Balchem (St. Gabriel, LA)
- …food safety, regulatory, and cost risks. + Apply sanitation principles effectively. + Effective project manager that knows how to prioritize and meet deadlines + ... LIMS systems. Knowledge & Experience: + Operated in an FDA regulated environment, ideally food or dietary supplement +...other relevant work experience. + Team Leadership Experience + Project Management & Change Management Experience + 2+ years… more
- Lactalis American Group Inc. (Buffalo, NY)
- …all LUSA suppliers (Raws & Packs, CoMan) with the Group QFS standards & FDA standard; to ensure Business Continuity & Reputation. Lead the transformation of Q&FS ... roadmap (WINSUP project ) established by Corporate. Leverage the talent of existing...team LUSA, R&D LUSA, suppliers, co-manufacturers and co-packers, quality manager of factories in LUSA to align duties with… more
- Stanford University (Stanford, CA)
- …5 or more studies, and work under the close direction of the manager (CRM), regulatory specialist and principal investigator(s). The CRCII will support industry, ... monitor data collection. Extract, analyze, and interpret data. + Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team… more
- Abbott (Sturgis, MI)
- …+ Experience utilizing project planning and execution tools + Knowledge of FDA - 21 CFR and other regulatory requirements for Infant Formula In compliance with ... responsibilities; share accountability for line budgetary decisions with direct manager . Track, trend, and continuously improve budgetary performance for… more
- PCI Pharma Services (Rockford, IL)
- …quality system procedures, industry, and business standards. + Effectively communicates project goals and progress to Supervisor / Manager . Investigates ... management + Interact with clients on an as-needed basis to support project milestones, scope changes and business development opportunities. + Develop and implement… more