Shurig Solutions Inc.
Recruiter Contact
Darwin Shurig
Chief Executive Officer
Medical Device RA Talent
International Regulatory Affairs Top Talent
I have known this RA/QA professional for over 8 years. 16+ years as a Medtech professional including 6 years of leadership experience with direct reports. Extensive product category experience and a Subject Matter Expert in getting products into challenging International Markets and leading International strategy for Japan, China, EEMEA, LATAM, and APAC. Has helped smaller companies and top 15 Medtech companies enter into new international markets successfully. Strong expertise in regulatory compliance, quality management systems, change management, and adherence to global regulations. Dedicated to fostering regulatory excellence and aligning project efforts with international standards in the medical device sector. Multilingual in English, Mandarin, Cantonese, and Japanese.
- 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, surgical, cardiac catheters, electro-mechanical devices, and combination device/drug products.
- Submission materials Expertise for FDA 510K, MDSAP, PMDA, NMPA, MFDS, HSA, TGA, CDSCO, TFDA, ANVISA, COFEPRIS
- Led a multi-country, multi-divisional product launch, successfully bringing a combination product to market despite perceived challenges, enhancing company revenue and market presence
- Established regulatory pathway for growing business in China, S. Korea, India, Taiwan, Thailand, Vietnam, Singapore, and Malaysia, enabling successful market entry and broadening product availability in multiple markets.
- Delivers training to other associates on major Asia market regulatory requirements and procedures, improving submission efficiency and overall compliance across multiple regions
- A results-driven leader who thrives in high-stakes environments to deliver excellence.