- Cook Medical (Bloomington, IN)
- Overview The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA ... liaison to engineering functions globally and locally to provide technical support for Regulatory Affairs - Develop new, and refine existing, systems that provide… more
- Lilly (Indianapolis, IN)
- …strategic solutions for the business. RLT also provides regulatory law advice to Global Regulatory Affairs , Manufacturing & Quality, Global Patient ... Provide legal counsel on matters related to drug, medical device and diagnostic clinical programs and regulatory ...other external activities. + Provide legal support to the Global Regulatory Strategy Teams and Americas Regional… more
- CSL Behring (King Of Prussia, PA)
- …delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other ... Regulatory CMC. + Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory … more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Philips (Washington, DC)
- …of 10+ years' experience in FDA Regulations, Global Regulatory Affairs , Policies and Standards within the Medical Device /Technology industry or Health ... Science & Policy Director is responsible for guiding the analysis of global regulatory requirements, policies and industry standards to identify their potential… more
- Edwards Lifesciences (Irvine, CA)
- …Surgical Structural Heart), and other Business Unit or Corporate functions such as Regulatory Affairs , Compliance, and others. . Reviewing and advising on a ... clinical investigations, etc.). . Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. . Other duties and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/ Device , and Global Regulatory Affairs . + Advanced knowledge of ... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be...Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements. The Global Vice President QARA Compliance is ... internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates...recommendations. + Coordinates and leads audit activities with all global regulatory agencies (eg FDA, Notified Bodies,… more
- Abbott (Pleasanton, CA)
- …Heart Failure. We have an exciting opportunity for a seasoned leader to join our Global Clinical and Regulatory Affairs team within the Heart Failure ... and resources) by working closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Regulatory Affairs , Medical Affairs , Reimbursement)… more
- Kelly Services (Bridgewater, NJ)
- …obtaining regulatory approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product ... ** Regulatory Affairs Specialist Labeling** Kelly(R) Science...SKILLS** + Knowledge of pharmaceutical, consumer or medical device industry product labeling processes for review and… more