Rachel C. Doran
Principal Regulatory Affairs Specialist | New Product Development
- Role
- Principal Regulatory Affairs Specialist at Cepheid
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Rachel C. Doran
A scientist with a regulatory lens. Interested in all aspects of in vitro diagnostic and medical device design and development (including Point of Care and CLIA Waived devices). I leverage a strong technical background in biologics and assay development to delve deep into technical and business questions and drive high-value discussions. I find fulfillment in working collaboratively to brainstorm and vet creative solutions to help cross-functional teams overcome development challenges, while maintaining business priorities and prioritizing safety and efficacy. Highly-motivated, Results-driven, and problem-solving mindset. Highly skilled in technical writing and verbal and written medical/scientific communication. Proven ability to quickly learn, adapt, and take on new challenges in order to drive projects to completion. When I\'m not in front of my computer, you can find me practicing risk assessment while freediving along the coast, or meandering my way along snowy ridgelines in Sierra Nevada mountains.
Experience
Principal Regulatory Affairs Specialist
Mar 2025 — Present
Provide guidance for core teams on interpretation and application of regulations, standards (US and EU) and FDA Guidances to drive R&D and clinical strategies for new product development• Identify project and regulatory risks, drive collaboration of subject matter experts to compile insight and key considerations, and communicate clear and holistic synopses of complex issues to both experts and non-experts to drive path forward• Assemble and manage cross-functional teams to critically evaluate, address, and justify solutions to complex regulatory/development-related challenges• Collaborate with assay, systems, and software teams to guide device design for devices intended for CLIA moderate, CLIA waived, Point-of-Care, and Near Patient Testing (EU) environments• Prepare FDA regulatory submissions/Q-subs and IVDR Technical Documentation
Education
University of California, Berkeley
Bachelor's Degree, Molecular Biology; Microbiology
University of California, Santa Cruz
Doctor of Philosophy - PhD, Molecular Cellular Developmental Biology; Biomedical Sciences and Engineering
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.