Sr. Specialist, Regulatory Affairs - Aliso Viejo

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. · ...

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. · ...

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

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. · ...

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 ...

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 · ...

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 ...

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 preparing strategy for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements. · As a contributing member on product development and operation teams. · ...

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 ...

The job description is for a Sr. Specialist, Regulatory Affairs position at MicroVention. The role involves preparing strategy for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requireme ...

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. · Provide regulatory support for U.S. and global submissions. · ...

The Associate Principal is responsible for establishing and preparing strategy for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements. · Bachelor's degree in a scientific or tech ...

Responsible for preparing strategy for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. · ...

The Post-Market Regulatory Affairs Specialist represents the Regulatory Affairs function and is responsible for knowledge of requirements and processes for maintaining a product in the clinical setting. · A strong candidate must have Medical Device IDE (clinical trial) experience ...

The Regulatory Affairs Specialist will provide support to the Director of Regulatory Affairs in relation to the Company's regulatory compliance efforts. · Assist in managing regulatory affairs matters for the company · Responsible for supporting registration/regulatory needs to m ...

· We are searching for a Director of Regulatory Affairs with deep expertise in invasive electromechanical medical devices and extensive experience preparing and submitting 510(k) notifications. · Leads the preparation, submission, and negotiation of 510(k) premarket notification ...