- Novant Health (Charlotte, NC)
- … regulatory entities including FACT, CLIA, NMDP, CIBMTR, and FDA . Responsible for qualification, validation, auditing of all critical processes,equipment, ... Novant Health. + Is a key member who ensures compliance with regulatory agencies, recommends an appropriate organizational structure and personnel plan for the… more
- Teleflex (Morrisville, NC)
- …understanding of FDA , ICH, GCP regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to ... clinical research. * Additional experience in clinical setting, biostatistics, IDE clinical studies or medical device product support. * Demonstrate aptitude in and knowledge of relevant therapeutic areas and ability to learn and integrate new/different… more
- BioLife Plasma Services (Raleigh, NC)
- …gain hands-on experience in operational production, including financial, regulatory , administrative, marketing, quality, facilities, and people management. Gain ... customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee… more
- Teleflex (Morrisville, NC)
- …throughout the organization. **Principal Responsibilities** * Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and ... the NC and CAPA systems as needed to structure activities. * Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries. * Partner with… more
- Teleflex (Morrisville, NC)
- …throughout the organization. **Principal Responsibilities** * Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and ... NC and CAPA systems as needed to structure activities. * Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries. * Define,… more
- Fujifilm (Holly Springs, NC)
- …to ensure the systems are properly qualified and validated per standards and regulatory requirements (eg, Food & Drug Administration ( FDA )) * Reads piping ... and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards while ensuring a successful integration of… more
- Cambrex High Point (Durham, NC)
- …and deliverables + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness and accuracy + ... TGA/DSC) + Able to comply to SOPs and have understanding of regulatory compliance + Working knowledge of scientific concepts, principles and procedures +… more
- Sysco (Concord, NC)
- …other related duties as needed. + Complies with local, state and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **QUALIFICATIONS** **Education** + ... High school diploma or general education degree (GED); or equivalent combination of education and related experience. + 2 or 4-year college degree in Business Management, Supply Chain Management or similar major preferred. **Experience** + 1-3 years related… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …sample labels per the Fill schedule * Provides 1st Batch Notice to Regulatory Affairs for controlled components * Issues and verifies stickered cartons to Packaging ... Strong knowledge of compliance standards with the Food Drug Administration ( FDA ), international governing entities and Good Manufacturing Practices (GMPs) +… more
- Chiesi (Cary, NC)
- …regional sales managers, corporate account managers, marketing, market access and regulatory team for advancement of medical/strategic objectives to ensure alignment ... professionals + Knowledge and experience in interpreting and adhering to FDA regulations regarding product promotion, scientific exchange, and health care… more