Shurig Solutions Inc.
Recruiter Contact
Darwin Shurig
Chief Executive Officer
Medical Device RA Talent
Manager or Principal Regulatory Affairs Top Talent
I have known this RA/QA professional for over 5 years. 22+ years as a Medtech RA professional including 7 years of design, quality, and systems engineering. Extensive product category experience including IVD, electro-mechanical, SaMD, leading US and International regulatory strategy. She has PMA, extensive 510 (k) submission experience, and extensive international experience including Russia, China, Japan, EU, and Canada. Unique experience with RoHS, Reach, and conflict minerals. Open to opportunities with established companies or in a start-up environment. The cultural fit and complexity of the product are personal drivers.
Regulatory & Quality Expertise
- A Dynamic Regulatory Affairs and Quality Assurance professional with extensive expertise in global medical devices including diagnostics, in-vitro diagnostics, MIS, electro-mechanical devices, and SaMD
- Extensive Submission experience for USA (510(k), PMA, Pre-Submissions), EU (Technical File and Declaration of Conformity), Canada, and Singapore
- Experience in submission package preparation for most other countries including China, Japan, S. Korea, Russia, Brazil
- Global Labeling Requirements SME
- Expertise with 21 CFR 820 and ISO 13485 Quality Management Systems, Safety Standards, Risk Management, & Design Controls
- Biomedical Engineering Background and driven leader who thrives in high-stakes environments to deliver excellence.