- Mentor Technical Group (Caguas, PR)
- …monthly Quality Review meetings. * Assists in gathering of information during FDA inspections, Notified Body Audits, Corporate Audits, etc. Performs other position ... order to meet the requirements of all applicable Quality System regulations (eg: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese… more
- PCI Pharma Services (Bedford, NH)
- …oral, and good written communication skills. + Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices. + Excellent communication skills ... SolidWorks, PLC & SCADA control system. + Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus. + Plant Engineering… more
- Sutter Health (Sacramento, CA)
- …privacy, and clinical safety risks. -Ensure compliance with HIPAA, HITECH, CMS, FDA (for medical device security), and state privacy regulations. -Oversee security ... & Skills** + Deep knowledge of HIPAA, HITECH, CMS, OCR enforcement, FDA guidance for medical devices, and healthcare-specific risk management frameworks. + Expertise… more
- Edwards Lifesciences (Irvine, CA)
- …MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Familiarity with FDA PMA applications. + Good knowledge of scientific research methodology, device development ... process, GCP, ICH guidelines and Global (US FDA , EU MDR) regulations. + Experience working in a cross functional, collaborative environment and comfortable… more
- Ultradent Products Inc (Salt Lake City, UT)
- …project life cycle, interpreting situations/ issues into compliant paths with regards to FDA , ISO, and Oratech standards. + Oversee updates to design history files ... + Strong understanding of regulatory guidance relevant to medical device, specifically FDA 's CFR820.30 and ISO 13485:2016 + 1-3 years of experience leading… more
- UTMB Health (League City, TX)
- …Principal Investigator and according to the protocol and the guidelines of the FDA and other regulatory agencies. + Applies knowledge in contributing to Good ... + Safely and properly administers investigational products research medication and FDA approved medications to research patients, under medical direction. + Maintain… more
- Mentor Technical Group (Monroe, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the Computerized Maintenance Management… more
- Integra LifeSciences (Plainsboro, NJ)
- …all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... Clean Room gowning. + Batch manufacturing experience. + Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International… more
- Edwards Lifesciences (Irvine, CA)
- …including proficiency with Microsoft Word + Familiarity with regulatory standards (ISO, FDA ) and design control processes. + Ability to work well independently and ... authoring deliverables for regulatory submissions to regulatory authorities including the FDA Aligning our overall business objectives with performance, we offer… more
- Dentsply Sirona (Sarasota, FL)
- …and documentation, including 510(k) submissions and CE marking + Knowledge of FDA regulations and international standards (eg, ISO 13485, MDSAP, EU MDR) + ... organizations + Prior technical writing experience and proven track record with FDA and EU regulatory submissions preferred Dentsply Sirona is an Equal Opportunity/… more