Celso Duran
Principal Regulatory Affairs Specialist | Medical Devices, 510(k), Technical File
- Role
- Principal Regulatory Specialist - Medtronic Robotics Assisted Surgery at Medtronic
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Celso Duran
Dynamic Regulatory Affairs leader with 10 years of expertise in regulatory strategy, operations, and submission writing, specializing in FDA QSUBs, FDA 510(k), and EU MDD/MDR. Demonstrated ability to communicate directly with FDA and Notified Bodies in an ethical and effective manner. Proven track record as the author of eight Class II 510(k) submissions for software (SiMD) and electromechanical devices, with extensive collaboration experience with FDA. Successfully authored EU Medical Device Directive (MDD) and Medical Device Regulation (MDR) submissions. Exceptional collaborator with strong communication and interpersonal skills, fostering strategic partnerships and promoting company reputation. Detail-oriented and capable of managing multiple projects in fast-paced, deadline-driven, and matrixed environments. A leader who excels in mentoring and coaching regulatory staff, developing innovative submission strategies, and supporting international market submissions.
Experience
Principal Regulatory Specialist - Medtronic Robotics Assisted Surgery
Aug 2024 — Present
Trusted core team member on cross-functional new product development teams, providing strategic regulatory guidance from concept through commercialization- 510(k) Submission Writing: Lead the preparation of FDA 510(k) for robotic instrumentation- Advertising and Promotion Compliance: Review and provide guidance on advertising and promotional materials to ensure compliance with regulatory standards, mitigating risk and enhancing market trust.
Education
Colorado State University
Master of Science, Biomedical Engineering
2010 — 2012
Rice University
Bachelor of Science, BioEngineering
2006 — 2010
Skills
- Matlab
- Fluorescence Microscopy
- U.s. Food and Drug Administration (Fda)
- Iso 14971
- Cad
- Western Blotting
- Iso 13485
- Technical Writing
- 21 Cfr 820.30
- Premarket Notification 510(K)
- Cell Culture
- Cell
- Tissue Engineering
- Regulatory Affairs
- Statistics
- Design of Experiments
- Technical Files
- Labview
- Pcr
- Laboratory
- Imagej
- Design Control
- Microscopy
- Medical Devices
- Molecular Biology
- Tissue Culture
- Scanning Electron Microscopy
- Public Speaking
- Mass Spectrometry
- Biomedical Engineering
- Gel Electrophoresis
- Experimentation
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