Shurig Solutions Inc.

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I have known this RA/QA professional for over 6 years.  16+ years of expertise crafting regulatory strategies for Class 1-3 medical devices in the US and EU markets around submission strategies, NPD, Auditing & Risk Management, and FDA/MDR regulations. Extensive experience in strategies for M&A activity for due diligence and integrations, strategic rollouts, and high-level project implementations.  

RA/QA, Compliance, & Project Management Expertise

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• Provided fractional and full-time regulatory leadership support to numerous Medical Device leaders, providing strategic advice on compliance, market access strategy, and helping to navigate complexities of changing regulations
• Integration regulatory lead on six acquisitions that successfully delivered to model; responsible for the development of integration of quality plans, integration of QMS systems and processes, all audit activities (Corporate, Notified Body, and FDA) with no significant findings, pre- and post-market regulatory activities, and engagement with regulatory authorities during the acquisition/integration process
• Evaluated potential targets as part of the business development team, completing due diligence activities, supporting the development of IOI and financial models, developing regulatory and quality strategy, and providing recommendations for acquisition on investments ranging from $10 - $200 million
• Developed and implemented over 50 get-to-market regulatory strategies ensuring compliance with global regulations and standards for devices within the Sports Medicine, Orthopedic, Trauma, OR Management, and Neurovascular therapies, with experience with permanent and resorbable implantables, active devices, SaMD, SiMD, RF technologies
• Experienced with developing regulatory strategies, considering requirements of 21 CFR Part 820, EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, and IEC 82304
• Supported hundreds of medical device clients successfully navigate the complexities of 2017/745 MDR and US FDA regulations for both legacy and new products
• Successfully expanded the Medical Writing and Regulatory teams in the US, resulting in a threefold increase in revenue over two years. Led global teams of up to 70 associates across 8 countries and 3 continents to support Medical Device Companies gain market access in the US, EU, Canada, and Australia
• Oversaw regulatory aspects of QMS, including creation and maintenance of RA procedures associated to design and development, change control, manufacturing transfer, control of standards, domestic and international registration readiness, release of product, and on-label compliance