- Beth Israel Lahey Health (Burlington, MA)
- …general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, research ... medical conditions and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA , OHRP and GCP regulations: + Ensures adherence to regulations. +… more
- Globus Medical, Inc. (Eagleville, PA)
- … requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other … more
- Colgate-Palmolive (Piscataway, NJ)
- …Knowledge of Regulatory environment across the globe + Knowledge of ICH/ FDA guidelines for stability and testing of new drug products **Compensation and ... + Create and maintain all required R&D documentation to ensure flawless, high- quality commercialization. + Maintain all required documentation under **GMP/GLP** per … more
- Cedars-Sinai (Los Angeles, CA)
- … FDA , OHRP, HIPAA and other agency guidelines. + Maintains high quality , up-to-date regulatory files (CITI and other training documents, financial ... integral to the successful management and administration of essential regulatory documents. The Research Associate II is responsible for...disclosures, FDA forms, CVs, medical licenses, etc.) for research studies.… more
- Bausch + Lomb (Tampa, FL)
- …of facility upgrades and new infrastructure. + Ensure compliance with applicable regulatory standards, including FDA cGMP guidelines, EU GMP Annex 1, ... to optimize manufacturing processes, increase operational efficiency, and enhance quality and safety standards. + Develop and maintain strong relationships… more
- ARTIDIS (Houston, TX)
- …and optimize measurement protocols, and ensure the highest standards of data quality , reproducibility, and regulatory compliance. You will work closely with ... quantitative data analysis. + Familiar with medical device operations, ISO 13485, FDA guidelines, CE Marking, and international regulatory frameworks. + Skilled… more
- ConvaTec (NJ)
- …Under Bond (TIB) process for goods entering the country for temporary purposes ensuring regulatory adherence. + Manage the FDA Import for Export (IFE) program ... Internal - Supply Chain, Sourcing, Plants, Warehousing, Distribution Centers, Marketing, Legal, Quality , Regulatory and other contacts as needed. Wide scope of… more
- Mentor Technical Group (PR)
- …in SOP writing or quality documentation. + Knowledge of regulations such as FDA 21 CFR Part 11, ISO 13485, ICH Q10, and GxP principles. + Proficiency in ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …timelines to ensure compliance with labeling regulations and guidance. Delivers high- quality submission labeling and artwork for complex drug products, specific ... to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global… more
- Carle Health (Urbana, IL)
- …medical equipment supports clinical workflows, enhance patient care and complies with regulatory requirements, include FDA , HIPAA, DNV and other relevant ... engineering solutions that align with organizational goals while ensuring regulatory compliance, system reliability, and cost-effectiveness. The Director will… more