Shurig Solutions Inc.
Recruiter Contact
Darwin Shurig
Chief Executive Officer
Medical Device RA/QA Top Talent
Principal Regulatory Affairs Top Talent
I have known this RA/QA professional for over 9 years. 18+ years as a Medtech professional including 7 years working in quality. Extensive product category experience including orthopedics, spine, surgical products, IVD products, MIS, combination products, etc. Strong expertise in regulatory compliance, quality management systems, change management, and adherence to global regulations. RA focused US expertise for the past several years but has strong quality experience in operational and design quality as well as risk management.
- Open to Individual Contributor opportunities with established companies or in a start-up environment. The cultural fit and complexity of the product are personal drivers.
Regulatory & Qualilty Expertise
- A Dynamic Regulatory Affairs and Quality Assurance professional with extensive expertise in global medical devices, orthopedics, spine, surgical products, IVD products, MIS, combination products, etc.
- Submit successful PMAs, 510(k)s, companion diagnostic, pre-submission, and de novo applications to FDA
- Prepare registration files for European registration and assist with the rest of the world's registration files including SFDA, TGA, ANVISA, Health Canada
- Certified Quality Auditor with expertise in design quality and DHF remediation
- Evaluate and/or approve proposed changes to products, processes, and controlled documents to determine the regulatory impact on marketed/existing products
- Prepare responses to customers, FDA, and foreign entities regarding complaints, MDR’s, and Vigilance Reports (ISO13485 & 21 CFR 820 compliance)