- Medtronic (Charlotte, NC)
- …as assigned/requested by management + All activities must be performed in compliance with the Quality System + Travel requirement (international possible): 20-40% ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- Reynolds American (Winston Salem, NC)
- …these spaces you could work in various spaces including compliance , validation, product submissions, clinical studies, statistics and biostatistics, analytical ... experience working in a laboratory setting. + Knowledge of FDA regulation processes or experience in another FDA... FDA regulation processes or experience in another FDA -related industry. + Open to relocate globally. + High… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …requirements and company policies / procedures. **Primary Responsibilities:** + Ensures compliance with Food and Drug Administration ( FDA ) regulations and ... and Abilities:** + Strong knowledge of Food and Drug Administration ( FDA ) regulatory requirements for good manufacturing practices. + Demonstrated spreadsheet and… more
- IQVIA (Durham, NC)
- …**CONNAISSANCES, COMPETENCES ET APTITUDES REQUISES :** + Connaissance des directives de la FDA (Food and Drug Administration) et de leur impact sur les operations + ... + Manage the standard operating procedures of the department and ensure compliance with ICH GCP guidelines. + Oversee the maintenance, review and implementation… more
- IQVIA (Durham, NC)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. Experience ... strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory, medical, and ethics guidelines. + Ensure… more
- Reckitt (Wilson, NC)
- …engineering, maintenance, and production teams. + Maintain regulatory alignment (GMP, FDA , ISO, EHS) and current schematics. + Execute preventive maintenance and ... and leadership skills. + Strong understanding of safety standards, regulatory compliance , and electrical codes..Strong knowledge of regulatory standards (eg, GMP, … more
- Reckitt (Wilson, NC)
- …initiatives to drive continuous improvement in safety, quality, and productivity. + Compliance & Documentation: Ensure all processes comply with cGMP, FDA , ... and oral solid dosage (OSD) forms. + Strong understanding of GMP, FDA regulations, and pharmaceutical manufacturing standards. + Hands-on experience with key… more
- Lilly (Concord, NC)
- …coaching to others in the areas of safety, quality, operational excellence, compliance , and continuous improvement. Direct line supervision for this role includes ... of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and/or OSHA. + Excellence in; interpersonal,...2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + Aseptic… more
- Cambrex High Point (Durham, NC)
- …and (where required) development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by ... regulatory guidance documents.* Strong knowledge of safety procedures and quality compliance for assigned area* Strong knowledge of cGMP requirements.* Strong… more
- Astellas Pharma (Sanford, NC)
- …support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry ... and reports. + Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. **Required Qualifications** + BS degree in… more