Project Manager, Regulatory Affairs - Irvine, CA

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 ...

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

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

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. This individual will lead regulatory strategy and submissions for · devices requiring ...

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. · ...

+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 ...

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. · ...

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 ...

+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 ...

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 · ...

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 ...

+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. · ...

We are seeking a Regulatory Affairs Manager to develop and execute global regulatory strategies for new and existing products. · ...

We are looking for someone with an international background who has good regulatory affairs knowledge, is very detail oriented and capable of working under pressure. · ...

Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre-, and post-market applications), query responses and correspondence tracking. Maintains regulatory information for competitive intelligence, l ...

This is a Senior Regulatory Affairs Specialist position for a Medical Devices Company in Irvine, CA. The job involves planning and implementing regulatory submissions and interacting with the regulatory body to further product approvals or clearance. · ...

We are seeking a Senior Manager of Regulatory Affairs to lead regulatory strategy and execution for Class III cardiovascular medical devices. The ideal candidate has deep experience with PMA submissions, EU MDR requirements, and post-market activities within high-risk implantable ...

The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases. · The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product developme ...

The Senior Regulatory Affairs Specialist will provide regulatory support for submissions and ongoing compliance with FDA regulations and other regulatory agencies. · ...

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees. · Here, you'll be supported in progressing – whatever your ambitions. · ...