Petra Teglas
@petrateglas
Regulatory Affairs Specialist experienced in IVD/CDx submissions, compliance, and lifecycle management.
United StatesWhat I'm looking for
I am a Regulatory Affairs Specialist with a strong scientific foundation and over five years of combined experience in regulatory affairs, biotechnology, and medical research, focused on IVDs, medical devices, and companion diagnostics. I have led IVDD-to-IVDR transitions, lifecycle management for Class II/III devices, and U.S./EU filings including PMA, 510(k), IDE, and CE Marking.
I excel at preparing and compiling regulatory submission documents, managing Veeva Vault (RIM MedTech), SAP, and mQMS, and coordinating Health Authority communications to reduce regulatory risk and accelerate approvals. I have applied working knowledge of ISO 13485, EU MDR, FDA QSR (21 CFR Part 820), and GMP across global submissions and change management initiatives.
I am authorized to work in the U.S., based in Seattle, WA, and open to remote opportunities nationwide. My achievements include developing a change management automation bot to reduce manual updates by 30% and creating an RA onboarding website to improve training efficiency.
Experience
Work history, roles, and key accomplishments
IIPrepared and compiled regulatory submission documents for FDA (PMA, 510(k), IDE) and EU (IVDR) filings for Companion Diagnostic and IVD products, managed timelines and quality control, and supported responses to regulatory authority inquiries.
Regulatory Affairs Specialist
Roche Services (Europe) Ltd.
Sep 2023 - Jan 2025 (1 year 4 months)
Led change management and IVDD-to-IVDR transformation for infectious disease IVDs, authored technical files and GSPR checklists for CE Marking, managed Veeva Vault and SAP entries, and coordinated Q&A with health authorities.
WRResearch Assistant Technician
Whitehead Institute for Biomedical Research
Jan 2022 - Jan 2023 (1 year)
Supported collaborative studies with Harvard Medical School, MIT and Boston Children’s Hospital by organizing and analyzing participant data, preparing SOPs, and ensuring regulatory and ethical compliance in research documentation.
Laboratory Analyst
SYNLAB Hungary Ltd
Aug 2020 - Aug 2021 (1 year)
Performed COVID RNA isolation, PCR, and STD testing to deliver timely and accurate diagnostic results and maintain laboratory quality standards.
Laboratory Assistant
University of Veterinary Medicine
Jan 2019 - Jan 2020 (1 year)
Conducted research on endocrine disruptors’ effects on brain cells, contributing experimental results and supporting neurotoxicity studies.
Student Laboratory Assistant
University of Szeged
Jan 2016 - Oct 2017 (1 year 9 months)
Performed food microbiology and analytical chemistry testing to support product safety and quality compliance in academic laboratory settings.
Education
Degrees, certifications, and relevant coursework
MEMIT Professional Education
Certification, Applied Data Science
2021 - 2022
Completed an Applied Data Science professional education certification covering practical data science tools and methods.
Hungarian University of Agriculture and Life Sciences
Master of Science, Biotechnology
2018 - 2020
Completed a Master of Science in Biotechnology, focusing on applied biotechnological methods and laboratory research.
University of Szeged
Bachelor of Science, Food Science
2014 - 2018
Earned a Bachelor of Science in Food Science / Food Engineering with coursework and lab experience in food microbiology and analytical chemistry.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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