- Cambrex High Point (Charles City, IA)
- …of facilities meet customer and business demands while complying with DEA, EPA, FDA and OSHA regulatory requirements and company standards. In addition to meeting ... All employees are required to adhere to DEA, EPA, FDA , OSHA and cGMP regulations as they relate to...tools + Thorough understanding of regulatory requirements regarding DEA, FDA , EPA, and OSHA. + Vision and demonstrated ability… more
- Hologic (Marlborough, MA)
- …C (Recalls), 21 CFR Part 806 (Reports of Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding ... field safety corrective actions. + Familiarity with FDA Industry Guidance for Recalls and guidance on distinguishing recalls from medical device enhancements. +… more
- Nissha Medical Technologies (Buffalo, NY)
- …scale-up meet cost, quality, and timeline objectives while complying with FDA and ISO 13485 standards. Key Responsibilities: + Program Execution Leadership: ... Regulatory & Quality Compliance: Ensure new product launches meet FDA 21 CFR Part 820 and ISO 13485 requirements....NPI or project management functions. + Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO… more
- Endo International (Raleigh, NC)
- …ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations ( FDA , EMA, ICH). This individual will provide overall QC leadership regarding ... to ensure they meet specifications.** + **Ensure adherence to FDA , EMA, and other regulatory standards, including PIC/S GMP...of change, and achievement of results** + **Contact with FDA as subject matter expert during site inspections and… more
- Grifols Shared Services North America, Inc (Van Nuys, CA)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The ... product development . Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project...Assists in the writing of regulatory applications to the FDA and other regulatory bodies . Partners with the… more
- Endo International (St. Louis, MO)
- …of manufacturing sites in the area of Quality Systems, and Training. + Interfaces with FDA and regulatory agencies outsite the US for events that include but are not ... results from direct and indirect reports. + Knowledge of FDA and International regulations and guidances in the area...+ Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host.… more
- Abbott (Milpitas, CA)
- …the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and ... biowearable products, ensuring on-time delivery within budget. + Implement FDA -compliant design control procedures. + Provide technical leadership and mentoring… more
- LifeCenter Northwest (Bellevue, WA)
- …patient safety risk reduction strategies while aligning practices with CMS, OPTN/UNOS, FDA , AATB and other applicable regulatory requirements and best practices. The ... and donor safety events to appropriate regulatory bodies and partners (eg OPTN/UNOS, FDA , AATB, transplant centers, tissue and eye banks). + Lead investigations of… more
- Philips (New Kensington, PA)
- …acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have proven expertise in Software ... EUMDR tech files, and Pre-Sub notifications submitted to the FDA . + Your skills include familiarity with FDA... FDA . + Your skills include familiarity with FDA , EU MDR, Health Canada, and other relevant international… more
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