- Oracle (Raleigh, NC)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more
- Chiesi (Cary, NC)
- …This intern will ensure Chiesi's products are produced and tested under fully FDA compliant systems and processes. This role is instrumental in supporting the ... product portfolio in compliance with technical requirements from existing and new FDA regulations, in accordance with CGMP principles. + Use of statistical… more
- Oracle (Raleigh, NC)
- …Health is transforming its development and regulatory processes to meet heightened FDA , MDR, and ISO 14155 standards and address ongoing patient safety, compliance, ... or regulated healthcare software sectors. . Extensive experience in FDA , MDR, and ISO 14155 compliance, clinical risk management,...with product lifecycle activities. . Ensure clinical compliance with FDA , MDR, and ISO 14155, acting as the central… more
- United Therapeutics (Morrisville, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... essential services that streamline patient access to therapy. Compliantly adhering to FDA and other regulatory guidelines, the Patient Navigator takes ownership of… more
- Biomat USA, Inc. (Kannapolis, NC)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more
- Oracle (Raleigh, NC)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- Oracle (Raleigh, NC)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more
- Endo International (Raleigh, NC)
- …ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations ( FDA , EMA, ICH). This individual will provide overall QC leadership regarding ... to ensure they meet specifications.** + **Ensure adherence to FDA , EMA, and other regulatory standards, including PIC/S GMP...of change, and achievement of results** + **Contact with FDA as subject matter expert during site inspections and… more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …interface with internal, external, customer and regulatory (USDA and/or FDA where applicable) inspectors regarding sanitation related non-conformance reports and ... by following and ensuring strict enforcement of Perdue Farms Standards, USDA, FSIS, FDA , GFSI, OSHA and customer requirements. 18. Leads or participates in the… more