Quality Assurance and Regulatory Specialist - Tustin, CA

We are seeking a detail‑oriented Regulatory Specialist with 2+ years of experience in clinical research regulatory operations. · Prepare, submit, and track regulatory documents for IRB/IEC submissions · Maintain regulatory binders · ...

We are seeking a detail‑oriented Regulatory Specialist with 2+ years of experience in clinical research regulatory operations. · This part‑time, on‑site role supports regulatory submissions, document maintenance, · compliance tracking, and study start‑up activities. · ...

We're a fast-paced, compliance-driven research clinic specializing in liver disease trials—from NASH and cirrhosis to hepatocellular carcinoma. This part‑time role supports regulatory submissions, document maintenance, compliance tracking, and study start‑up activities. · ...

The Cosmetics Regulatory Operations Specialist supports Cellese's global regulatory operations through meticulous preparation of regulatory documents, · Prepare standardized regulatory document packets for all global markets, · Route final drafts to the Regulatory Manager for sig ...

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 ...

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

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 ...

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 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 ...

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 ...

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 · ...

As a Regulatory Affairs Specialist II, · you will support new product developments/product modifications, · IVDR implementation and international product. · ...

+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 ...

Responsible for planning, coordinating and implementing regulatory Submissions for products that require government approval. · ...

The Regulatory Coordinator I is responsible for the preparation, · organization and implementation of regulatory research documents such as pre-study activities, · initiation, execution and reporting on the various status of research tasks in accordance with FDA guidelines, · ICH ...

+10 months duration. Three days a week in Irvine, California. Responsible for planning regulatory submissions for products requiring government approval. · Apply relevant regulations to further product submissions of basic to medium complexity. · Contribute to strategic direction ...

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