Andrea Ruth

Current

• Principal Consultant at ALR Regulatory Consulting, LLC

Past

• RA/QA Consultant at Volcano Corporation
• Associate Consultant at Marion Weinreb and Associates
• Consultant, Regulatory Affairs at Oraya Therapeutics

7 more...

Recommended

2 people have recommended Andrea

Connections

257 connections

Industry

Medical Devices

Andrea Ruth’s Summary

Experienced professionals in Medical Device Regulatory Affairs and Quality Assurance.

• Global Regulatory Advice and Strategy (VC stage to Large Enterprise)
• Project Management
• QS Development/Implementation
• Advertising and Promotion Review
• Regulatory Affairs Submissions (FDA and International)
• Medical Writing
• Contract Recruitment in Quality Assurance and Regulatory Affairs

Andrea Ruth’s Specialties:

• Expertise in Device Software, Complex Systems and Single-use Disposables (Catheters, Ultrasound, RF, Minimally Invasive Surgery MIS, Microwave, Laser)
• Regulatory Affairs Publishing - 510(k), IDE, PMA, Technical File (TF), Design Dossier (DD)
• Risk Analysis/Risk Management (FMEA, FMECA, HA, ISO 14971)
• Auditing (Supplier, Internal, Gap Analysis, QSR, QSIT, ISO 13485, MDD)

Additional Information

Andrea Ruth’s Contact Settings

Interested In:

• consulting offers
• new ventures
• expertise requests
• business deals
• reference requests
• getting back in touch