- Cardinal Health (Helena, MT)
- …& Filing + Quality Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance ... provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to...+ Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls… more
- Lilly (Indianapolis, IN)
- …as required. + Provide legal counsel on matters related to drug, medical device and diagnostic clinical programs and regulatory submissions in the US and ... also provides regulatory law advice to Global Regulatory Affairs , Manufacturing & Quality, Global Patient...provide legal advice regarding regulations and strategy on drug, medical device (software and hardware) and diagnostic… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Abbott (St. Paul, MN)
- …join our Global Regulatory Operations team and lead portfolio management of regulatory programs across medical device business units, international ... regulatory teams, and global regulatory operations. This role provides strategic leadership and stewardship...practices in program management, the Director will help achieve-and exceed- medical device division goals. This position serves… more
- Mount Sinai Health System (New York, NY)
- …studies + 3+ years of direct experience in Regulatory Affairs , Clinical Affairs or Quality Assurance within the Medical Device Industry Preferred: + ... **Job Description** A Regulatory Compliance Coordinator position is currently available within...medical knowledge preferred. **Responsibilities** + Protocol development: Provides regulatory support to clinical trial project teams. Work with… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Philips (Bothell, WA)
- …+ You've acquired a minimum of 12+ years' experience in Regulatory Affairs within FDA regulated Medical Device /Consumer electronics environments. + You ... The Director of Regulatory Compliance is responsible for formulating and executing... matters of diverse product categories - Class I medical device , consumer goods and cosmetics. +… more
- Edwards Lifesciences (Irvine, CA)
- …clinical investigations, etc.). . Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. . Other duties ... and other Business Unit or Corporate functions such as Regulatory Affairs , Compliance, and others. . Reviewing...negotiating clinical trial agreements and associated contracts in the medical device or pharmaceutical industry or at… more
- Philips (Washington, DC)
- …a minimum of 10+ years' experience in FDA Regulations, Global Regulatory Affairs , Policies and Standards within the Medical Device /Technology industry or ... The Regulatory Science & Policy Director is responsible for...Director is responsible for guiding the analysis of global regulatory requirements, policies and industry standards to identify their… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and partner concerns for the field action committee. Facilitate discussions with medical affairs and other relevant function to understand issue's impacts ... **Job Description Summary** The Quality Systems and Regulatory Staff Lead ensure robust governance and execution...discipline. + Minimum 7 years of progressive experience in medical device Quality Assurance, with a proven… more