Principal Specialist, Regulatory Affairs - Uwchlan Township

The job involves regulatory review of new supplier & part qualifications. It includes submissions to EU and FDA. The candidate should be able to negotiate and build relationships with FDA, EU Notified Bodies, Health Canada etc. · The experience in preparing and submitting regulat ...

Supports necessary regulatory activities required for product market entry. · ...

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, · Develop and implement medical device regulatory strategies for West's administration and safety system product portfolio with an emphasis on gaining re ...

The Principal Specialist, Regulatory Affairs (Medical Devices) is responsible for influencing department regulatory processes and procedures, · developing strategies for worldwide regulatory approval, · preparing global submissions including Premarket Notifications, · Global Regi ...

The Sr. Specialist, Regulatory Affairs is responsible for influencing department regulatory processes and procedures developing strategies authoring reviewing and supporting global registrations including Premarket Notifications China NMPA Registrations Technical Documentation fo ...

Job Summary · The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures. · ...

We're on a mission to make good health more affordable and accessible to help millions around the world enjoy healthier lives. · ...

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. · The Principal Specialist, Regulatory Affairs (Medical Devices) is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regul ...

The Regulatory Affairs Sr. Specialist is responsible for influencing department regulatory processes and procedures, developing strategies, authorizing reviews, and supporting global registrations including Premarket Notifications. · The Sr. · ...

The Regulatory Affairs Sr. Specialist is responsible for influencing department regulatory processes and procedures. · The position includes supporting internal and external customer regulatory requests. · Bachelor's with 5+ years of medical device, pharmaceutical or regulatory e ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · Contribute to the design and execution of global regulatory strategy for Ocugen's gene therapy programs. · Collabor ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · ...

We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. · ...

We're Teva, a leading innovative biopharmaceutical company. · Here, you will be part of a high-performing, · inclusive culture that values fresh thinking and collaboration.You'll have the room to grow, · the flexibility to balance life with work, · and the opportunity to better h ...

The Recall Regulatory Specialist III will be responsible for leading OUS field action execution activities including managing Field Action Strategy Team meetings and coordinating document packages to notify regulatory agencies of field action activities. · ...

Job summary: · This is a mid-level Regulatory Affairs position responsible for integrating regulatory knowledge throughout the product lifecycle and coordinating projects effectively. · Responsibilities:Participate in multidisciplinary teams and communicate regulatory requirement ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · ...

This is a mid-level Regulatory Affairs position responsible for integrating regulatory knowledge throughout the product lifecycle and coordinating projects effectively. The role supports the Regulatory Affairs team by communicating regulatory strategies and preparing essential do ...

A growing medical device organization seeks a Manager, Regulatory Affairs to lead U.S. regulatory submissions for Class II and Class III products. · Bachelor's degree in engineering, life sciences, or related technical field (Master's preferred) · 8+ years in the medical device i ...

Cytokinetics is seeking a highly motivated Intern to join its Regulatory Affairs group. The internship will provide hands-on insights and working experience of several regulatory operations and affairs functions. · ...