Regulatory Affairs Specialist - Lake Forest, CA

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 ...

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 ...

The Sr. Regulatory Affairs Specialist will support develop drive timely preparation regulatory submissions updates necessary obtain maintain regulatory approvals Endologix products. · This position will support regulatory strategy review design changes manufacturing changes speci ...

We are seeking a Sr Regulatory Affairs Specialist to join our mission-driven Regulatory Affairs team. · Develop implement and maintain regulatory processes SOPs with a strong commitment to Integrity ensuring compliance with current evolving global regulations prioritizing product ...

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 position requires a Regulatory Affairs Specialist to plan and implement regulatory submissions for medical devices. The ideal candidate should have mid-level experience and knowledge of healthcare-related regulations. · ...

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 ...

The Post-Market Regulatory Affairs Specialist represents the Regulatory Affairs function.The position 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) e ...

The 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 a s ...

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 ...

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. · ...

Regulatory Affairs Specialist · Plan, coordinate and implement regulatory submissions for healthcare products requiring government approval. · ...

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 · ...

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

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 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. · ...

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 · ...

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 ...

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