Savannah Arthur

Regulatory Affairs Specialist II
Cook Medical
Winston Salem, NC 27105

I am a results-driven Regulatory Affairs Specialist II with over 5 years of experience in the medical device industry, focused on ensuring global regulatory compliance across complex markets. At Cook Medical, I lead initiatives for EUMDR implementation, RIMS, and regulatory strategy for Class I and II devices across the EU, UK, and Switzerland. My expertise lies in building and maintaining technical documentation, driving successful CE submissions, and ensuring seamless alignment with evolving international regulatory standards. I’ve consistently delivered on high-stakes deadlines—achieving full MAP buildouts, regulatory extensions, and post-market deliverables across multiple product lines.

With a foundation in biochemistry and biology, complemented by an MBA in Healthcare Administration, I bring both technical depth and strategic insight. I’ve led cross-functional efforts that improved manufacturing processes, introduced compliance-driven technologies, and enhanced documentation systems—positively impacting product quality and patient outcomes. I also bring a global mindset, having represented my company internationally and led a successful Class B technology submission to India—recognized publicly by the Governor of India.

Beyond regulatory expertise, I’m passionate about mentorship, training, and being a collaborative partner across departments. My values center on staying grounded, helping others grow, and leading with purpose. Whether managing high-volume regulatory submissions or improving internal processes, I’m committed to innovation, continuous learning, and advancing medical device technologies that make a difference in people’s lives.

• Western Governors University
• Ohio Valley University

Q

What do you attribute your success to?

I attribute my success to a strong foundation in process and technical engineering, along with a commitment to cross-functional collaboration—especially in the medical device space. One of my proudest achievements was leading a project that allowed my company to represent the U.S. in India, where I was the sole specialist able to submit a Class B technology for approval. The device was successfully cleared, and the Governor of India even shared the success story on LinkedIn. It was a clear demonstration of regulatory compliance, technical execution, and international collaboration.

Q

What’s the best career advice you’ve ever received?

The best career advice I’ve ever received is that you get paid to learn. No one transitions into a new role knowing everything—what matters is how you apply the skills and knowledge you already have, while staying open to growth. Every position is an opportunity to learn, adapt, and build on your foundation. That mindset has shaped how I approach challenges and continuous development throughout my career. Staying innovative and deeply connected in what you do lies the essentials to success within the business.

Q

What advice would you give to young women entering your industry?

Build resilience and perseverance. This will help you overcome doubts from others and trusting your abilities is crucial. Rather than being discouraged by setbacks, view them as learning opportunities that strengthen your resolution. Advocate for yourself. Don't be afraid to voice your achievements, goals, and needs. Learn to be assertive and communicate your value clearly. Prioritize work-life balance. Balancing professional and personal life is key for long term success. Network proactively. Attend industry and professional events like RAPS. Use these opportunities to connect and build a report within your network. Most importantly, always stay humble and kind.

Q

What are the biggest challenges or opportunities in your field right now?

One of the biggest challenges in our field right now—especially within a global company like Cook—is aligning multiple entities under a single, standardized process. When we conduct reviews for transparency and technology transfer, we often find that different departments or regions follow varying procedures. This lack of a unified process can slow down regulatory submissions and create inconsistencies. The opportunity lies in streamlining these workflows into one cohesive system, which would enhance compliance, efficiency, and collaboration. It’s a complex transition, but one that’s critical for long-term success.

Q

What values are most important to you in your work and personal life?

The values most important to me—both in my work and personal life—are staying deeply and innovatively connected, maintaining faith and grounded-ness, and leading with humility. I believe your attitude shapes your work-life balance and the impact you have on others. I strive to help those around me and support those coming up behind me, because you never know when paths will cross again. To me, it’s important to be a human being, not just a human doing—treating others with respect and empathy, regardless of position or title.

Locations

Cook Medical

Winston Salem, NC 27105

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