Scott Thiel
Corporate Head of Regulatory Affairs | Market Authorization Strategy | Regulatory Policy & Intelligence | FDA, EMA, Health Canada | MDSAP, QMS | MedTech Thought Leader
- Role
- Corporate Head of Regulatory Affairs at Hologic, Inc at Hologic, Inc.
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Scott Thiel
I’m a seasoned medical device regulatory affairs expert committed to helping companies bring life-enhancing and life-saving technologies to patients across the globe. I guide teams through every phase of the product lifecycle—from development and global submissions to post-market oversight and failure remediation—with clarity and dedication. My goal is to uncover and share the intent behind the regulations in a way that is understandable to the audience. I’ve collaborated with organizations of all sizes, simplifying complex regulatory challenges for cross-functional teams and shaping solutions that align with each company’s unique structure. I tailor compliance strategies that are both practical and scalable, enabling long-term success. I’ve built quality systems from the ground up, often parallel to ongoing product development, ensuring seamless integration and regulatory alignment. I speak at industry conferences, sharing insights particularly focused on medical device software development, and continue to engage with peers on advancing best practices. My leadership in medical device interoperability includes directing coalitions and contributing to federally funded projects that prioritize safe, connected technologies. Lately, I’ve been actively shaping the conversation around how to regulate artificial intelligence in medical devices—an area that demands both foresight and nuance. I stay grounded in purpose, strategic in execution, and focused on elevating global health through compliant, effective innovation. I welcome the opportunity to collaborate or exchange perspectives on regulatory strategy—feel free to connect.
Experience
Corporate Head of Regulatory Affairs at Hologic, Inc
Mar 2023 — Present · Marlborough, MA, US
Education
Ball State University
Bachelor of Science - BS
Indiana Wesleyan University
Executive MBA
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.