- Tecomet (Claypool, IN)
- …Responsibilities** + Maintaining applicable quality system, environmental, and FDA requirements/certifications. + Facilitate operator owned quality program. + ... management. + Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations. + Good Manufacturing Practices (GMP) and Good… more
- Tecomet (Lansing, MI)
- …Responsibilities** + Maintaining applicable quality system, environmental, and FDA requirements/certifications. + Facilitate operator owned quality program. + ... management. + Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations. + Good Manufacturing Practices (GMP) and Good… more
- Unilever (Austin, TX)
- …will also serve as the primary liaison with regulatory agencies such as the FDA and FTC. In addition to managing day-to-day quality and regulatory functions, this ... recurring issues as necessary. + Conduct internal audits and support third-party, FDA , and regulatory inspections. + Generate and analyze quality KPIs and trends… more
- University of Washington (Seattle, WA)
- …they relate to clinical trials. Act as a divisional resource regarding audits ( FDA , sponsor, and Institutional Review Boards). Serve as divisional resource for ... FDA Investigational New Drug applications and communication. + Develop...maintain standardized research procedures that ensure Program compliance with FDA , State, and inter-institutional regulations. + Oversee regulatory, records,… more
- Koniag Government Services (Silver Spring, MD)
- …comprehensive research, analyze intricate scientific data, and communicate findings to FDA staff and stakeholders. The primary responsibilities of this role include: ... + Draft detailed reports and presentations, effectively communicating technical information to FDA staff and subject matter experts + Serve as a subject matter… more
- Insight Global (Lincolnshire, IL)
- …documentation for Corporate Systems & Innovation to meet and maintain internal RA/QA and FDA requirements and will be a key participant as needed in external audits, ... including those performed by the FDA . Essential Duties and Responsibilities: 1. Responsible to provide...& Innovations teams to support internal and external audits ( FDA , ISO, MDSAP, HITRUST, etc.). 4. Acts as Business… more
- Endo International (Rochester, MI)
- …Practices (GLP) and Good Manufacturing Practices (GMP) + Ensure compliance with FDA and other regulatory standards + Follow safety procedures and handle hazardous ... in a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Has expanded knowledge of… more
- Kelly Services (Norcross, GA)
- …diagnostics (IVDs). The role will support global regulatory compliance across US FDA , Health Canada, and EU Notified Body requirements, providing regulatory guidance ... alignment. * Prepare and submit regulatory filings, including US FDA 510(k), Health Canada licenses, and EU Notified Body...IVD experience. * Hands-on experience preparing submissions to US FDA , Health Canada, and EU Notified Bodies within the… more
- Zimmer Biomet (Austin, TX)
- …validation, verification, regression testing, and cybersecurity to ensure compliance with FDA , ISO 13485, IEC 62304, and ISO 14971 standards. Monogram's ... for robotic medical device systems, ensuring compliance with applicable FDA and ISO regulations + You will develop and...and serve as the software quality SME during internal, FDA , and Notified Body audits + You will ensure… more
- Katmai (Brilliant, OH)
- …monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. **ESSENTIAL DUTIES & RESPONSIBILITIES** + ... Control. + Prepare documentation and systems for compliance with the FDA requirements. + Conduct and participate directly in quality inspections, internal… more