Senior Specialist, Regulatory Affairs - San Juan Capistrano, CA

The Sr. Specialist, Regulatory Affairs will create, evaluate and execute domestic and international regulatory tasks related to global submissions, technical file compilation, · facility registrations and strategy to drive market growth worldwide.Create, evaluate and execute dome ...

Provide regulatory guidance in product design, clinical studies, market authorization strategies, labeling. · Review and edit product submissions and other communications prepared by junior department members. · ...

+Job summary · We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products.This role will assist in executing global regulatory strategies, preparing and maintaining registration dossiers, and ensuring compliance wit ...

We are seeking a Regulatory Affairs Associate II to support medical device regulatory activities with a strong focus on EU MDR compliance.Ensure regulatory readiness and successful submissions across global markets. · ...

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 ...

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. · ...

We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products. · Prepare and manage U.S. and global regulatory submissions, including FDA and CE technical documentation · Support execution of global regulatory strategi ...

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

The Regulatory Affairs Associate will have a strong understanding of FDA EU and worldwide submission requirements. · ...

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 · ...

Are you interested in working for an organization that is making a difference in people's lives every day? · ...

Direct medical device regulatory experience with recent hands-on EU MDR 2017/745 experience and FDA interaction required. · ...

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 · ...

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

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The Regulatory Affairs Associate will be responsible for managing regulatory affairs related to medical devices. · The ideal candidate should have direct experience in medical device regulatory affairs with recent hands-on EU MDR 2017/745 experience, · a Bachelor's Degree in phar ...

Regulatory Affairs Associate II job in San Clemente requiring a Bachelor's Degree in pharmacy or related subject and RAC Certification. Proven strong understanding of FDA and EU submission requirements. · ...

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 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 (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 ...

The Sr Specialist Regulatory Affairs will create evaluate and execute domestic international regulatory tasks related to global submissions technical file compilation facility registrations special projects strategy to drive market growth worldwide. · * Create evaluate and execut ...