Principal Regulatory Affairs Specialist - Tustin

This role will focus on supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities impacting all products currently CE Marked under the IVD Directive. · ...

This role supports the European Union In Vitro Diagnostic Regulation (IVDR) transition activities impacting all Bio-Rad products currently CE-marked under the IVD Directive. · Support IVDR transition projects by revising assigned technical files using the latest approved template ...

The Regulatory Affairs Specialist will support the Director of Regulatory Affairs in regulatory compliance efforts. · Strong understanding of regulatory requirements · Effective research and analytical skills · Strong verbal and written communication skills · ...

Job Title: · Regulatory Affairs Specialist II · Join our client's Regulatory Affairs team to support the transition to the EU's In Vitro Diagnostic Regulation (IVDR), impacting all CE-marked IVD products. · ...

The Regulatory Affairs Specialist will provide support to the Director of Regulatory Affairs in relation to the Company's regulatory compliance efforts. This includes managing regulatory affairs matters for the company, ensuring compliance with regulatory requirements for Company ...

+Regulatory Affairs Specialist II with working knowledge of FDA, and CE marking requirements for IVD products. · +Support the IVDR project by revising assigned technical files. · Update labeling specifications to meet IVDR requirements. · ...

+This position requires support for US and EU regulatory submissions. · +Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology) · 7+ years of experience Regulatory Affairs required · +ResponsibilitiesSupport US and EU regulatory submissions (exerc ...

+Job summary · Regulatory Affairs is responsible for planning coordinating and implementing regulatory Submissions for products that require government approval. · +Demonstrates working knowledge of healthcare-related regulations · Demonstrates in-depth knowledge of preparing a s ...

The Regulatory Affairs Specialist will provide support to the Director of Regulatory Affairs in relation to the Company's regulatory compliance efforts. · ...

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 ...

Regulatory Affairs is responsible for planning coordinating and implementing regulatory Submissions for products that require government approval. · ...

We are looking for a highly motivated Medical Affairs Clinical Specialist to be part of our Medical Affairs team in Johnson & Johnson MedTech – Neurovascular. · ...

Johnson & Johnson is recruiting for a Medical Affairs Clinical Specialist located in Irvine, California. · We are looking for a highly motivated Medical Affairs Clinical Specialist to be part of our Medical Affairs team in Johnson & Johnson MedTech – Neurovascular.This role provi ...

+We are looking for a highly motivated Medical Affairs Clinical Specialist to be part of our Medical Affairs team in Johnson & Johnson MedTech - Neurovascular. · ++Serve as the primary study medical lead for company sponsored clinical studies. · +Support the clinical trial team t ...

This Senior Regulatory Affairs Specialist role supports the regulatory strategy and lifecycle management for Class II devices at a commercial-stage medical device company. The position involves hands-on experience with FDA submissions and collaboration across cross-functional tea ...

The Boston Scientific Urology business unit provides proven solutions to treat urology diseases. The Senior Regulatory Affairs Specialist supports submissions and regulatory compliance for product development process and sustaining engineering projects. · Develops and implements ...

We re partnering with a growing medical device company to hire a Senior Regulatory Specialist to help drive FDA submissions and product approvals across a portfolio of Class II devices. · ...

As a Regulatory Affairs Specialist II, you will support new product developments/product modifications, IVDR implementation, and international product. Represent RA on global project teams for new or modified in vitro diagnostic devices (IVD). Manage global RA Change Request Proc ...

Senior Regulatory Affairs Specialist is responsible for planning, coordinating and implementing regulatory Submissions for products that require government approval. · Demonstrates working knowledge of healthcare-related regulations · Demonstrates in-depth knowledge of preparing ...

Support US and EU regulatory submissions; track timelines and document milestone achievements. Participate in assessing and collating regulatory impact and developing regulatory strategy. · ...