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 7 years. 20+ years as a Medtech professional including 6 years of leadership experience with direct reports. Extensive product category experience including combination products leading US and International regulatory strategy. He has extensive 510 (k), PMA supplement personal submission experience and oversight as a leader in the US and extensive international experience including the EU, Canada, and AsiaPac. Expertise in Q-Sub meetings and submissions, supporting clinical trials, and helping clear warning letters and consent decrees with appropriate protocol and submission strategy. Open to Individual Contributor or Leadership opportunities with established companies or in a start-up environment. The cultural fit and complexity of the product are personal drivers.
Regulatory Expertise
- A Dynamic Regulatory Affairs and Quality Assurance professional with extensive expertise in global medical devices, orthopedics, in-vitro diagnostics, human cell tissue products, electro-mechanical devices, and combination device/drug products.
- Proven track record of success in U.S., E.U., and Canadian regulatory submissions, driving global regulatory strategies to completion.
- Skilled in leading teams through New Product Development, remediation initiatives, and product lifecycle maintenance.
- Successfully authored and submitted U.S. 510(k)s, HDE Supplements, PMA Notices, IDE, Q-Submissions, Canadian New Submissions, Amendments, and E.U. MDR filings.
- Developed and maintained ISO 13485, MDSAP, and HCT/P systems with exceptional compliance standards. Spearheaded critical Warning Letter remediations, resulting in the removal of compliance risks and bolstered regulatory confidence.
- A results-driven leader who thrives in high-stakes environments to deliver excellence.