Project Manager, Regulatory Affairs - Cromwell Irvine, California, United States

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 ...

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 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 · ...

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

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. · ...

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 ...

+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. This includes managing regulatory affairs matters for the company, ensuring compliance with regulatory requirements for Company ...

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. · ...

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 ...

+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 ...

+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. · ...

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

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 ...

Sr. Regulatory Affairs Specialist responsible for providing strategic input and technical guidance on product lifecycle planning and regulatory requirements. · ...

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. · ...

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. · ...