Hi, I'm Randy Parry - Innovative Regulatory Affairs Expert | AI/ML Med Devices | SaMD | Digital Health | Startup Advisor
I thrive at the intersection of cutting-edge AI/ML and regulatory science in medical devices, devising creative compliance pathways that bring life-changing innovations to patients. My passion is bridging complex tech with clear regulatory strategy.
At a glance
Curated signals on strengths, focus areas, and how they can help.
Authored multiple successful 510(k) submissions and an EU MDR Technical File for SaMD.
Currently driving regulatory strategy for AI/ML-powered medical devices in neuroscience.
Can provide expert guidance on SaMD, AI/ML, and digital health regulatory pathways.
🚀 Career trajectory
Foundation in Life Sciences & Research
Began with a strong academic background in Molecular Biology/Biotechnology, fostering a deep understanding of scientific principles and research methodologies.
✦ Molecular Biology
✦ Biotechnology
✦ Research
Transition to Medical Device Regulation
Moved into regulatory affairs, applying scientific knowledge to medical device compliance, focusing initially on general medical devices and expanding to software.
✦ Regulatory Affairs
✦ Medical Devices
✦ Quality System
Specialization in Digital Health & AI/ML
Developed deep expertise in Software as a Medical Device (SaMD), AI/ML algorithms, and digital health, navigating complex submissions for innovative technologies.
✦ SaMD
✦ AI/ML
✦ Digital Health
✦ 510(k)
✦ MDR
Current Role: Regulatory Affairs Manager - Software
Leading regulatory strategy and execution for software-centric medical devices at a cutting-edge neuroscience company.
✦ Regulatory Strategy
✦ Software Medical Devices
✦ Leadership
💪🏻 Superpowers
Pioneering SaMD Regulatory Pathways
Expert navigation for AI/ML and Digital Health devices.
✦ Authored four 510(k) submissions and one EU MDR Technical File for SaMD.
✦ Successfully implemented Predetermined Change Control Plans for AI/ML algorithms.
✦ Developed regulatory strategies for diverse medical devices including SiMD and mobile apps.
Bridging Science and Compliance
Translating complex technologies into regulatory success.
✦ Leverages a multidisciplinary background in Molecular Biology/Biotechnology.
✦ Applies technical aptitude to create novel regulatory solutions.
✦ Ensures product compliance while fostering company innovation.
Startup & Digital Health Enabler
Accelerating innovation in emerging health tech.
✦ Proven ability to guide startups through regulatory challenges.
✦ Focuses on compliance for Software as a Medical Device (SaMD).
✦ Supports development from concept to market authorization.
I'm excited about
✦ Connecting with forward-thinking professionals in AI/ML and digital health.
✦ Exploring emerging regulatory challenges and innovative solutions.
✦ Discovering opportunities to advise and collaborate on groundbreaking health tech.
I can help with
✦ Providing expert guidance on SaMD, AI/ML, and digital health regulatory strategies.
✦ Assisting companies in navigating FDA and international regulatory submissions.
✦ Offering creative solutions to complex compliance challenges for medical device innovators.
I would love your help on
✦ Insights into novel AI/ML applications in healthcare beyond medical devices.
✦ Introductions to leaders in early-stage digital health startups.
✦ Discussions on the future landscape of regulatory science and technology.
