Regulatory Affairs Speciliast

A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week.The Regulatory Affairs Consultant will be focused on the hands-on development of a Special 510k regulatory submission with a deadline of...

Regulatory Affairs Specialist This is an exciting opportunity to join an industry leading biotech company leading. The Regulatory Affairs Specialist will be responsible for supporting In Vitro Diagnostic Regulation (IVDR) transition activities that impact products currently CE Marked under the IVD Directive. This includes preparing revision of technical...

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...

Regulatory Affairs SpecialistThis is an exciting opportunity to join an industry leading biotech company leading. The Regulatory Affairs Specialist will be responsible for supporting In Vitro Diagnostic Regulation (IVDR) transition activities that impact products currently CE Marked under the IVD Directive. This includes preparing revision of technical files...

Regulatory Affairs SpecialistThis is an exciting opportunity to join an industry leading biotech company leading. The Regulatory Affairs Specialist will be responsible for supporting In Vitro Diagnostic Regulation (IVDR) transition activities that impact products currently CE Marked under the IVD Directive. This includes preparing revision of technical files...

Regulatory Affairs SpecialistThis is an exciting opportunity to join an industry leading biotech company leading. The Regulatory Affairs Specialist will be responsible for supporting In Vitro Diagnostic Regulation (IVDR) transition activities that impact products currently CE Marked under the IVD Directive. This includes preparing revision of technical files...

Senior Regulatory Affairs Specialist will beresponsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance of all new and existing products. In this role, you will prepare product submissions, handle license renewals, and provide periodic updates...

About Us: Bright Uro is an early-stage medical technology company headquartered in Irvine, CA.We are building the next generation of diagnostic devices for Urology. Utilizing advanced hardware, software, and data science, we can unlock new data streams and offer actionable insight for clinicians. The Director of Quality and Regulatory Affairs ensures...

About Us: Bright Uro is an early-stage medical technology company headquartered in Irvine, CA. We are building the next generation of diagnostic devices for Urology. Utilizing advanced hardware, software, and data science, we can unlock new data streams and offer actionable insight for clinicians. The Director of Quality and Regulatory Affairs ensures...

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We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Senior Specialist, Regulatory Affairs page is loaded Senior Specialist, Regulatory Affairs Apply locations USA - California Irvine time type Full time posted on Posted 2 Days Ago job requisition id...

We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...

We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...

Our client, is a Fortune 100 medical device company that specializes in critical care technology, structural heart innovation, and surgical monitoring. They have a long-standing culture of integrity, collaboration, and innovation.Job Description:The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and...

Our client, is a Fortune 100 medical device company that specializes in critical care technology, structural heart innovation, and surgical monitoring. They have a long-standing culture of integrity, collaboration, and innovation.Job Description:The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and...

Job Description   Description     The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filings. Utilizing...

Job Description The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Supports regulatory objectives for the management of IVD/CDx...

Job Title: Regulatory Affairs Specialist Job Responsibilities: This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies. General Description and Duties: To perform this job...

Job Description Purpose: The Director Regulatory Affairs Global Regulatory Lead in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include...

Coursework, seminars, and/or other formal government and/or trade association training requiredProven expertise in Microsoft Office Suite including Word, PowerPoint and ExcelGood written and verbal communication skills and interpersonal relationship skillsGood problem-solving, organizational, analytical and critical thinking skillsSolid knowledge and...