Associate Specialist – Premarket Regulatory Affairs - Rancho Santa Margarita

We are seeking a Regulatory Affairs Specialist (RAS) with strong IVD experience to support the transition from IVDD to IVDR. This role is responsible for revising and maintaining IVD technical documentation, supporting IVDR labeling conversions, and managing regulatory notificati ...

We are seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions.This role will support execution of global regulatory strategies, ensure compliance with FDA, EU, and international requirements, and collabor ...

We are seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions. · Provide regulatory support for U.S. and global submissions. · ...

+Responsible for planning coordinating and implementing regulatory submissions for products requiring government approval. · Demonstrates working knowledge of healthcare-related regulations · Demonstrates in-depth knowledge of preparing a submission · ...

Planifica, coordina e implementa la presentación de solicitudes regulatorias para productos que requieren aprobación del gobierno. · ...

Be at the forefront of innovation – shape regulatory strategies that bring breakthrough therapies and life-changing technologies to patients around the world. · ...

Are you interested in working for an organization that is making a difference in people's lives every day? We're a high-growth company · ...

We are a high-growth company with an entrepreneurial spirit that produces reliable products supported by proven clinical data. · - Familiarize with the design manufacture and clinical use of Terumo Neuro products · - Perform specific regulatory tasks for new/modifified product · ...

We are a high-growth company looking for an intern in Regulatory Affairs to join our team. · The Regulatory Affairs team is responsible for executing regulatory strategies and obtaining approvals for our products. · This internship will provide valuable experience and skills in r ...

The position of Principal Regulatory Affairs is responsible for establishing and leading the strategy for worldwide product approval submission activities. This involves managing multiple large projects or processes. · ...

Responsible for establishing preparing and leading the strategy for worldwide product approval submission activities As a recognized expert manage multiple large projects or processes Responsible for submission activities focused on USEUCanada and for ensuring compliance to FDA a ...

We're seeking an experienced Regulatory Affairs professional to lead global product submission and compliance activities for Class II/III medical devices in the neuro and peripheral space. · ...

We're a high-growth company, customer-focused with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. · ...

+Be at the forefront of innovation – shape regulatory strategies that bring breakthrough therapies and life-changing technologies to patients around the world. · ...

The Principal Regulatory Affairs will establish prepare lead strategy worldwide product approval submission activities manage multiple large projects processes As recognized expert manage submission activities focused US/EU/Canada ensure compliance FDA international regulatory ag ...

Responsible for timely preparation and submission of organized scientifically valid global regulatory affairs submissions. Interacts with internal departments and external representatives. · ...

Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions. · ...

+Job summary · The Sr. Specialist, Regulatory Affairs will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market g ...

We are seeking a Sr Regulatory Affairs Specialist to join our mission-driven Regulatory Affairs team. · Develop implement and maintain regulatory processes SOPs with a strong commitment to Integrity ensuring compliance with current evolving global regulations prioritizing product ...

The Sr. Regulatory Affairs Specialist will support develop drive timely preparation regulatory submissions updates necessary obtain maintain regulatory approvals Endologix products. · This position will support regulatory strategy review design changes manufacturing changes speci ...