Senior Regulatory Affairs Specialist - Irvine

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 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 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 · ...

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 ...

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. · ...

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

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. · ...

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

+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 ...

This job involves planning coordinating and implementing regulatory submissions for products requiring government approval. · Demonstrates working knowledge of healthcare-related regulations. · Demonstrates in-depth knowledge of preparing a submission. · ...

+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. · ...

+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 ...