- University of Utah (Salt Lake City, UT)
- …national and international research consortia. 7. Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research ... and effective communication skills also required. Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; and… more
- Taiho Oncology (Princeton, NJ)
- …Responsible for authoring TOI documents submitted to Regulatory Authorities (eg FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, ... procedures in a timely and accurate manner. + Understand publishing standards for FDA and MAA. + Manages and oversees medical writing deliverables assigned to… more
- Terumo Neuro (Aliso Viejo, CA)
- …submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral ... regulatory experience. 3. Strong technical writing skills as evidence by successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health… more
- GN Hearing (Shakopee, MN)
- …cost control, and increased efficiency + Prepare and participate in ISO, FDA , Internal Audits, and tours as required + Utilize Entrepreneurial Operating System ... + Experience working in a regulated environment (ISO 13485:2016, ISO 9001, FDA QSR) + Leadership experience across multi-functional teams + Experience with Lean… more
- Actalent (Belleville, IL)
- …actions. + Ensure analytical methods and documentation meet regulatory requirements for FDA submissions and CMC packages. + Maintain compliance with cGMP and ... small-molecule, and compounded pharmaceuticals. + Understanding of regulatory guidelines ( FDA , ICH) and cGMP standards. + Excellent technical writing skills.… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities** + ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Integra LifeSciences (Plainsboro, NJ)
- …of the following regulations and guidelines: US Food and Drug Administration ( FDA ) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the ... procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO Certification and surveillance audits and customer audits. +… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …products. **Responsibilities:** + Assess necessity for reporting changes to FDA /Notified Body for proposed device modifications. Prepare robust reporting ... device regulations, 21 CFR 820 Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice… more
- Aerotek (Smyrna, TN)
- …proficiency in MS Office. + Minimum 5 years of related manufacturing experience in an FDA facility preferred. + 3 years of experience in a non- FDA facility is ... considered average. + Previous experience in GMP or Food Manufacturing is a plus. **Why Work Here?** Join a stable company offering great benefits, including an ESOP program. Enjoy working with a team committed to continuous improvement in a supportive and… more
- J&J Family of Companies (Santa Clara, CA)
- …in full compliance with the company's Design Control requirements and consistent with FDA , ISO, and MDD requirements. + Support the prototype and development of ... regulatory efforts through understanding of relevant standards and interpretation of FDA Guidance documents. + May require active participation in research meetings,… more