Shurig Solutions Inc.
Recruiter Contact
Darwin Shurig
Chief Executive Officer
Medtech RA Top Talent
SaMD Regulatory Affairs Leadership Top Talent
RA professional with 20+ years of Medtech professional experience, including 9+ years of leadership oversight, mentoring, and building teams. Extensive product category experience includes implantables, cardiovascular, neurological, robotics, MIS, hardware, software, imaging, mobile devices, and leading US and international regulatory strategy. A Subject Matter Expert for SaMD, SiMD, AI, ML, Cybersecurity with submission experience for Breakthrough Technology, 510 (k), and PMA Supplements. Open to opportunities with established companies or in a start-up environment. The cultural fit and complexity of the product are personal drivers, but wearable technologies, AI-driven solutions, robotic platforms, and monitoring are key interest areas.
Regulatory & Compliance Expertise
- A Dynamic Medtech Regulatory Affairs and Compliance SME for SaMD, SiMD, AI, ML, software, and advanced technologies
- Extensive Submission experience for (510(k), PMA Supplements, Breakthrough Technology, & EU MDR
- Expertise with implantables, cardiovascular, neurological, robotics, MIS, hardware, software, imaging, mobile devices, etc.
- 9 Years of Leadership experience with teams of up to twenty
- Extensive International expertise in EU, Canada, Asia, South America, and the Middle East
- Supported all premarket activities and post-commercialization complaint handling, surveillance, and continuous improvement as well as creation of PMO for company-wide program management
- Biomedical Engineering Background and a driven leader who thrives in high-stakes environments to deliver excellence