Medical Device Regulatory Support Specialist

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...

Device Regulatory Specialist - A Role in Pharmaceutical and Medical Device DevelopmentJob DescriptionWe are seeking a skilled Device Regulatory Specialist to join our team in the design, development, and commercialization of medical device technology solutions. Our organization is focused on delivering innovative healthcare solutions for patients...

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,...

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...

Regulatory Support RoleWe are seeking a highly organized and detail-oriented professional to provide administrative and regulatory support within our Medical Devices department.Key Responsibilities:Process regulatory cases, correspondence, and certificates of free saleManage data entry, updates, and document control for compliance with EU and national...

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...

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...

Medical Device Manufacturing SpecialistA Medical Device Manufacturing Specialist is responsible for developing, implementing, and optimizing high-performance manufacturing processes for medical devices.Main Responsibilities:Design and develop advanced manufacturing processes for medical devicesCollaborate with cross-functional teams to support new product...

Job Title: Clinical Regulatory SpecialistThe role of a Clinical Regulatory Specialist is pivotal in the development of innovative medical devices. Key responsibilities include supporting design development, verification, clinical trials, validation, and regulatory approval.Key ResponsibilitiesCoordinate global clinical trial execution, including site...

Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for post-market activities for medical devices.This role requires a strong understanding of global device adverse event/incident reporting requirements, with a focus on US, EU and international...