- Abbott (Abbott Park, IL)
- …the Medical Affairs team to assist customers with high impact clinical educational programs + Organize and conduct regular customer business reviews to assist ... the Health System + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures,… more
- Abbott (Sylmar, CA)
- …varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required.Medical device industry experience preferred. + ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Cook Medical (Bloomington, IN)
- …leading, and collaborating with cross function teams including quality, engineering, production, clinical , and regulatory affairs .- Provide leadership in the ... CAPAs as necessary.- May interface with internal or 3rd party audits. (eg FDA , Notified Body, etc.)- Drive continuous improvement efforts through facilitating,… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …QEII** + Bachelor's degree. + Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs . + Other fields can be considered with the appropriate ... Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting plant trainings and initiatives. **Job Description** We… more
- System One (Park Ridge, NJ)
- …+ Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements ... advantage + Expert Microbiology and Sterilization understanding + Demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC + Strong… more
- Envista Holdings Corporation (Orange, CA)
- …performance, reliability, and clinical outcomes, while maintaining compliance with FDA , ISO 13485, and other regulatory standards. Design & Engineering ... teams including product management, project management, manufacturing, quality assurance, regulatory affairs , and customer support to ensure seamless… more
- Sumitomo Pharma (Providence, RI)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. **Job ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Genentech (South San Francisco, CA)
- …I-IV), medical writing, and data analysis, with a thorough understanding of US regulatory / FDA requirements. + Demonstrated ability to coach, mentor, and develop ... partner functions (including Research, Product Development, Commercial, and Government Affairs ) and collaborating across the dynamic health ecosystem to ultimately… more
- United Therapeutics (Research Triangle Park, NC)
- …of United Therapeutics Corporation (UTC) products in accordance with ICH Good Clinical Practice (GCP), applicable regulatory guidelines and company standard ... Will support strategic clinical product development as well as Global Medical Affairs . + Provide medical expertise, advice, and guidance to members of the … more
- Sanofi Group (Cambridge, MA)
- …and deliveries. Engage with cross-functional teams (business, commercial, medical affairs , clinical affairs , cybersecurity, privacy, pharmacovigilance, ... edge. + Collaborate with cross-functional teams to prepare for regulatory inspections and internal audits, ensuring compliance and addressing...+ 5+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software… more