- Fujifilm (Durham, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** Experience: + Zero to two years of experience with Web Development, Web Performance testing tools. + Basic Experience in C#, JavaScript, and PowerShell. + Experience in .NET, Microsoft Team… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of progressive… more
- Mentor Technical Group (Durham, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global… more
- Fujifilm (Holly Springs, NC)
- …* Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QCAD ... team to investigate any project challenges with necessary risk assessment tools and techniques, as needed * Supports best practices for TT and PPQ strategies globally, as required * Coordinates and supports QCAD Bioassay lab activities and provide training for… more
- Fujifilm (Holly Springs, NC)
- …* Bachelor's with 2 years of relevant work experience * Experience with FDA Audits or similar organization management * Experience with GMP regulations **WORKING ... CONDITIONS & PHYSICAL REQUIREMENTS** PHYSICAL REQUIREMENTS PHYSICAL DEMANDS Will work in environment which may necessitate respiratory protection X No Yes May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing… more
- Fujifilm (Holly Springs, NC)
- …driven organization + Experience working in a CGMP facility and with FDA regulations **Preferred Requirements** + Master's degree in engineering or related ... scientific field + 6-10 years' experience in a pharmaceutical / biological manufacturing operation + Previous experience leading an automation team at a greenfield site **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** Will work in environment which may… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience + 4+ years previous sales… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + All other functions and or responsibilities that may be assigned by management. **Qualifications:** + Associate degree in computer science or related field, or equivalent work experience. + Minimum of 4… more