Medical Affairs Project Manager

Job DescriptionThe Senior Clinical Project Manager will collaborate with core team associates, extended core team associates, and Global Clinical Affairs associates to provide Medical and Scientific Affairs support within various phases of product development and performance evaluation of BD devices.This role serves as the project lead for moderate to high...

Job SummaryThe Regulatory Affairs Specialist 2 works closely with cross-functional teams to develop and implement regulatory strategies. The primary goal is to ensure compliance with applicable regulations and facilitate the commercialization of medical devices in targeted markets. Key responsibilities include:• Maintaining current knowledge of regulatory...

Key ResponsibilitiesThe Senior Clinical Project Manager will be responsible for planning, implementing, overseeing, managing, and completing performance evaluation studies involving human bio-specimen procurement for analytical and clinical studies conducted within Europe.This role requires collaboration with cross-functional teams, including Medical and...

Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets.The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

Job OverviewCook Medical seeks a highly skilled Regulatory Affairs Specialist 2 to ensure regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). As a key member of our team, you will serve as a communication liaison between Cook manufacturers and the EU regulatory authorities.Main Responsibilities:Maintain an excellent...

OverviewThe Regulatory Affairs Specialist 2 helps develop regulatory strategies and performs activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

Job Description:The Regulatory Affairs Specialist 2 at Cook Medical plays a crucial role in developing and implementing regulatory strategies for medical devices. This position requires a deep understanding of global regulations, including ISO 13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21 CFR Part 820.Responsibilities:Maintain...

Overview The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR).The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical's non-EU manufacturers.The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook...

OverviewCook Medical seeks a highly skilled Regulatory Affairs Specialist 2 to develop and implement regulatory strategies for commercializing medical devices in target markets.This role serves as a liaison between the manufacturer and local affiliates, distribution partners, or regulatory authorities, ensuring effective communication and collaboration.

Overview">The position of Regulatory Scientist 2 is a key role within Cook Medical Incorporated. The successful candidate will be responsible for the development and generation of post-market surveillance plans and reports for Cook Ireland medical devices.In addition to this, the Regulatory Affairs Specialist will perform various activities associated with...

Overview The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical's non-EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook...

About BD BiosciencesBD Biosciences is a leading provider of high-quality flow cytometry and single-cell genomics solutions, scientific research and clinical laboratories.Main ResponsibilitiesRepresent Medical and Scientific Affairs in the product development team, also supports the Core Team activities (document and design review and approval, informed...

At BD Medical, we are committed to advancing the world of health. Our team of experts is dedicated to developing innovative solutions that transform the lives of our patients and customers.About the RoleThe Senior Clinical Project Manager will play a critical role in leading and overseeing clinical performance evaluation studies for our devices in Europe....

About the RoleThe Senior Clinical Project Manager will collaborate with the core team associates, extended core team associates, and Global Clinical Affairs associates to provide Medical and Scientific Affairs support within the various phases of product development and performance evaluation of the BD devices.This role serves as the project lead for...

Clinical and Post Market SurveillanceAt Cook Medical, we are committed to delivering innovative medical devices that improve patient outcomes. As a Regulatory Scientist 2, you will play a critical role in ensuring the safe and effective use of our products. Your responsibilities will include:Maintaining an excellent understanding of global medical device...

Job OverviewThe position of Regulatory Affairs Specialist 2 at Cook Medical Incorporated is responsible for developing regulatory strategies and performing activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets.This role serves as a communication liaison between the manufacturer...

Job Description Summary The Senior Clinical Project Manager (Sr. CPM) will lead and oversee clinical performance evaluation studies for BD devices in Europe, focusing on the procurement of human bio-specimens for analytical and clinical studies. This role involves collaborating with cross-functional teams, including Medical and Scientific Affairs, Clinical...

About the PositionWe are seeking a talented Regulatory Scientist 2 to join our team at Cook Medical. As a key member of our regulatory affairs department, you will play a vital role in ensuring the compliance of our medical devices with global regulations.Key ResponsibilitiesDevelop and implement regulatory strategies for Cook Medical's medical...

Job OverviewBD Medical seeks a highly skilled Senior Clinical Project Manager to lead and oversee clinical performance evaluation studies for BD devices in Europe. This role involves collaborating with cross-functional teams to manage and complete studies in compliance with regulations like Good Clinical Practices (GCP), IVDR, and GDPR.The ideal candidate...