- Leidos (Rockville, MD)
- …collaboration services. + Manage Windows and macOS endpoint engineering, including device lifecycle management, patching, imaging, compliance baselines, and ... lead and oversee engineering teams focused on M365/Azure environments, endpoint device management, unified communications platforms, mobile device solutions, and… more
- Fujifilm (Columbia, SC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... enterprise quotes. + Understand the specialized requirements for quoting regulated medical software, hardware, and consulting; ensuring accurate compliance ,… more
- Globus Medical, Inc. (Audubon, PA)
- …advantage but not essential + Minimum of 5 years of experience is needed within Medical Device Quality Assurance/ Quality Systems with experience in FDA and CE ... At Globus Medical , we move with a sense of urgency...Operations Quality, and Sterile Manufacturing Quality. This position ensures compliance with applicable regulatory requirements (FDA QSR, ISO 13485,… more
- Hologic (Marlborough, MA)
- …Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding field safety corrective actions. + ... with FDA Industry Guidance for Recalls and guidance on distinguishing recalls from medical device enhancements. + Understanding of MEDDEV 2.12/1 guidelines for… more
- Teleflex (Wyomissing, PA)
- …personnel to support 510(k)s, Canada License applications, European Union (EU) Medical Device Regulations (MDR) submissions, and other regulatory deliverables, ... regulatory activities to meet submission, departmental, and quality system compliance requirements. The Senior RA Associate will partner with... medical technology. * Minimum 2 years of medical device regulatory experience or equivalent. *… more
- West Pharmaceutical Services (Exton, PA)
- …regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety ... addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government...5 years of relevant experience + 2+ years of medical device regulatory experience preferred + Experience… more
- Element Materials Technology (Eagan, MN)
- …specializes in microbiological testing and analytical support for antimicrobial, pharmaceutical, medical device , and related regulated manufacturing and consumer ... testing that supports client needs, focusing on R&D and lot release for medical device manufacturing. Methods include TOC, endotoxin, bioburden and general… more
- Veterans Affairs, Veterans Health Administration (Grand Island, NE)
- …with providers and allied health colleagues regarding treatment. Ability to assess device to ensure structural soundness and compliance with prescription and ... outcomes and refine the treatment plan to improve patient compliance and satisfaction. The 2-page Resume requirement does not...to accommodate or treat a wide range of complex medical conditions which include unusual problems or complications The… more
- Danaher Corporation (Austin, TX)
- …of healthcare technologies and market trends + 8+ years' experience working in the medical technology, medical device , or pharmaceutical industry in ... the Danaher Business System which makes everything possible. The Senior Director, Medical & Scientific Affairs - Infectious Disease is responsible for setting the… more
- Lundbeck (Deerfield, IL)
- …non-field-based Medical Affairs experience in the pharmaceutical, biotech or medical device industry. + Minimum 2+ years' experience with contribution ... Director Medical Affairs, Rare Epilepsies Evidence Generation Requisition ID:...reviewer in the promotional materials review process, ensuring accuracy, compliance , and scientific integrity. + Collected, analyzed, and translated… more