Project Manager, Regulatory Affairs - Irvine

Planifica, coordina e implementa la presentación de solicitudes regulatorias para productos que requieren aprobación del gobierno. · ...

· 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. · Assist in managing regulatory affairs matters for the company · Responsible for supporting registration/regulatory needs to m ...

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 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 ...

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

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 ...

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 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 ...

+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 ...

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

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

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 ...

+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 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. · ...