Global Medical Device Regulatory Expert

Regulatory Specialist for Medical DevicesThis position requires a subject matter expert in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory compliance.The successful candidate will maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest...

Job Description:Senior Associate, Regulatory Affairs">This role is a hybrid position that requires working 3 days a week onsite in Dublin. The Senior Associate will support post-market activities for Administration and Safety System medical devices, collaborating with management.West Pharmaceutical Services focuses on delivering life-saving injectable...

Job SummaryThe role of Regulatory Affairs Specialist is crucial for the post-market activities of medical devices, supporting departmental regulatory processes and procedures, strategies, authoring, reviewing, and supporting global registrations.Main Responsibilities:Support regulatory strategies for OUS medical devices and combination products, ensuring...

Job TitleClinical Regulatory Specialist - Global OpportunitiesJob DescriptionThis role offers a chance to work on the development of pioneering structural heart devices through design, verification, clinical trials, validation, and regulatory approval.Key ResponsibilitiesCoordinate global clinical trial execution, including site activation, enrolment, follow...

Regulatory Affairs ExpertiseThe Senior Specialist in Regulatory Affairs is responsible for post-market activities for medical devices, supporting departmental regulatory processes and procedures. Main Responsibilities:Develop and execute regulatory strategies for OUS medical devices and combination products.Create regulatory documentation such as CIAs,...

At the core of our mission to improve patient lives, we're a dedicated team connected by a shared purpose.Job SummaryThis role is pivotal in supporting our regulatory processes and procedures, strategies for worldwide post-market surveillance activities, and maintaining knowledge of current US, EU, and international regulations/guidelines/policies related to...

Job OverviewThis role is responsible for leading the technical regulatory compliance of medical devices and drug-device combination products. The successful candidate will have a strong understanding of FDA, EU, and ISO standards, regulations, and guidance related to design control and regulatory compliance.Key ResponsibilitiesMaintain awareness of current...

Job OverviewThe primary role of the Regulatory Affairs Specialist is to manage post-market activities for medical devices. The specialist will support global regulatory processes and procedures, develop strategies, author documents, and collaborate with international registrations.Main Responsibilities:Develop regulatory strategies for overseas medical...

Lead Regulatory Expert for Device DevelopmentThis is a senior role that requires expertise in regulatory compliance, strategy development, and team leadership. As a Lead Regulatory Expert, you will be responsible for ensuring that device development projects comply with relevant regulations, standards, and guidelines.Key Responsibilities:Develop and maintain...

Regulatory Affairs Specialist RoleThe position of Regulatory Affairs Specialist is responsible for overseeing post-market activities for medical devices, supporting regulatory processes and procedures, authoring and reviewing regulatory documentation, and ensuring timely and high-quality execution of all deliverables.Key Responsibilities:Develop and...