Shurig Solutions Inc.
Recruiter Contact
Darwin Shurig
Chief Executive Officer
Medical Device RA Top Talent
VP or Senior Director Regulatory Affairs Top Talent
I have known this RA/QA professional for over 7 years. 22+ years as a medical device regulatory and clinical professional, including 15+ years of leadership experience with direct reports and team building. An SME for the PMA process with extensive experience in regulatory strategy, compliance, and the submission process for Class III devices and device systems from concept to international launch. Comprehensive expertise for Class II 510 (k), IDE, CE Mark, and EU MDR oversight. Product experience for spine, orthopedic, combination products, collagen, absorbable implant systems, IVD, surgical, etc. Expertise in Pre-Sub FDA meetings, supporting clinical trials, leading successful remediation projects, and supporting successful manufacturing site transfers. Open to Leadership opportunities with established companies or in a start-up environment. The cultural fit and complexity of the product are personal drivers. Open to title dependent on the size of the company and role responsibilities.
Regulatory Expertise
- A PMA and 510 (k) Subject Matter Expert for Class II and III Medical Devices in the USA and EU
- Class III Spinal Arthroplasty devices managed from initial concept through to international launch (CE Marking), IDE approval, and US FDA PMA submissions filed for both devices.
- Extensive Leadership experience leading leaders with teams of up to 70+. Expertise in building new teams
- Successfully led remediation efforts for DHF and MDR, including all files passing on initial attempt
- Experience with Merger & Acquisition activities and manufacturing site transfers
- Leading Product Development, Operations, Clinical, and Marketing groups to discuss the US, and EU regulatory requirements and pathways to market
- A results-driven leader who thrives in high-stakes environments to deliver excellence