- ThermoFisher Scientific (Greenville, NC)
- …for equipment, processes, computer software, and cleaning validation, ensuring compliance with industry standards and regulatory requirements. + Test Planning: ... : Familiarity with relevant industry standards and regulations (eg, ISO, FDA , GMP) is highly desirable. + **Certifications** : Relevant certifications (eg,… more
- J&J Family of Companies (Wilson, NC)
- …for equipment and information technologies. + The resolution of unexpected complex compliance or lab instrument and system issues as they arise Qualifications: + ... with QC analytical equipment is required. + Knowledge of cGMP regulations and FDA /EU guidance is required. Other Requirements: + An unquestionable level of integrity… more
- CaroMont Health (Gastonia, NC)
- …by College of American Pathologists, Joint Commission, CLIA, AABB, CMS, and FDA . Responsible for coordinating off site inspections in conjunction with College of ... testing procedures, specimen requirements and basic knowledge of laboratory compliance . Excellent customer service and interpersonal skills required. Strong computer… more
- Novant Health (Charlotte, NC)
- …compliancewith regulatory entities including FACT, CLIA, NMDP, CIBMTR, and FDA . Responsible for qualification, validation, auditing of all critical ... and throughout Novant Health. + Is a key member who ensures compliance with regulatory agencies, recommends an appropriate organizational structure and personnel… more
- Dentsply Sirona (Charlotte, NC)
- …Reviews and interprets regulatory requirements and guidance documents to ensure compliance + Coordinates regulatory activities with internal teams and external ... documentation, including 510(k) submissions and CE marking + In-depth knowledge of FDA regulations and international standards (eg, ISO 13485) **Key Required Skills,… more
- Fujifilm (Raleigh, NC)
- …of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent in ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and systems + Ensure that the procurement operations function operates in full compliance with health, safety, and regulatory requirements + Ensure that all requests… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and open communication to hit daily deliverables and maintain GMP compliance . You will collaborate closely with QA, warehouse, manufacturing, and maintenance… more
- Fujifilm (Raleigh, NC)
- …work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent in ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Eliassen Group (Raleigh, NC)
- …applicable. BIG PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation. There will ... further and achieve more with their technology solutions, financial, risk & compliance , and advisory solutions, and clinical solutions. With offices from coast to… more