- Datavant (Raleigh, NC)
- …Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory -grade real-world data (RWD) solutions through tokenization, data linkage, and ... Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is...all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). +… more
- GRAIL (Durham, NC)
- …process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks. This position is **onsite full-time** , with **5 days ... validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485, FDA , and other applicable standards. + Provide scientific and technical support to… more
- Biomat USA, Inc. (Kannapolis, NC)
- …responsible for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance, and achievement of production goals. This role provides ... all center activities align with company standards, SOPs, and applicable regulatory requirements. **Summary** : Assists with operational management of a Plasma… more
- Dentsply Sirona (Charlotte, NC)
- …studies. This can be sponsored studies on non-approved products as well as on regulatory approved and marketed products. **What are we expecting from you?** In this ... for medical devices that are sufficient for ISO 14155, EU MDR and FDA . + Preparation and submission of clinical study documentation to Independent Ethics… more
- Perdue Farms, Inc. (Raleigh, NC)
- …Perdue's food safety and quality goals and ensure compliance with all regulatory agencies and customers' expectations. To ensure all products produced meet or ... exceed all customer, regulatory and company requirements as they relate to food...working relationship and act as a plant liaison with FDA and USDA staff. + Develop staff through appropriate… more
- Cardinal Health (Raleigh, NC)
- …You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team develops ... that support the Medical Device segment's Product Management, Marketing, Quality, Regulatory , and Product Design/R&D teams. Cardinal Health has deployed Oracle Agile… 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 ... Ensure that the facility operations are in compliance with regulatory procedures and guidelines; accountable for the review and...advanced working knowledge and experience with cGMPs and US FDA , EU and JP requirements + 5+ years of… more
- Edwards Lifesciences (Raleigh, NC)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across… more
- United Therapeutics (Morrisville, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... SOPs, test methods, and product specifications to ensure alignment with regulatory requirements, internal quality standards, and industry best practices + Review… more
- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... therapeutic research and industry trend analysis, including competitive positioning, regulatory changes, domain-specific insights, and opportunities + Drive innovation… more