Daniel Khuc

A regulatory affairs professional in the Bay Area of Northern California, Daniel provides a diversified background to the role of the regulatory representative within the medical device industry. He received his bachelor's degree from the University of California at Berkeley, completing his studies in bioengineering in December 2011. His past studies featured synthetic biology applications, bioMEMS manufacturing and design, and medical devices; his current professional interests include cybersecurity strategy and game mechanics within medical devices, unconventional and unique international case studies, and regulatory data infographics.


EDUCATION

University of California, Berkeley (2011)

B.S. Bioengineering with Honors – GPA: 3.72

Activities and Societies: Tau Beta Pi Engineering Honor Society, California Marching Band

San José State University (Unfinished)

M.S. Biomedical Engineering (Medical Devices concentration) – GPA: 3.98

Activities and Societies: Biomedical Engineering Society (BMES)

 

EXPERIENCE

REGULATORY AFFAIRS ANALYST | VARIAN MEDICAL SYSTEMS

March 2015 – Present | Palo Alto, CA

• Review and compile regulatory submissions for medical devices (Class II)
• Administration of daily activities that support registrations, submissions, and reporting activities
• Monitoring and analyzing worldwide regulatory requirements for applicable company products
• Evaluate regulatory compliance of submission documents, product materials, design process records
• Communication and team-focused application of regulatory plans within device release programs
• Develop and handle regulatory correspondence with governmental agencies, auditors, and standards organizations
• Actively providing updated regulatory information to manufacturing, QA, engineering, and business as needed
• Prepare and update documentation for technical files, FDA submissions, Medical Device license applications

Related Skills: 510k Submission Processes, Technical File / Design Dossier, Regulatory Guidance, Recognized Consensus Standards, Regulatory Documentation, Health Canada licence amendments/applications, CE Marking, Wireless Devices Standards, Cybersecurity Regulations, RoHS, Complaint Handling, Promotional and Advertising Reviews, FDA and EU Regulations

 

Worship Director, Principal Organist and Musician | Irvington Presbyterian Church

May 2008 – February 2017 | Fremont, CA

• Lead a team of musicians and singers in weekly meetings, special events, and rehearsals
• Design and manage visual and audio presentation media for effective and engaging services

Related Skills: Musical Performance (Piano, Organ, Synthesizer, Guitar, Vocal), Live Sound Mixing, Audio and Visual Equipment Management, Presentation Software, Visual Communication

 

Project Developer | Precision SurgiCenter

March 2012 – December 2014 | Fremont, CA

• 100+ viewing hours of orthopedic, cardiovascular, and general surgeries at ambulatory facility
• Became familiar with surgical sterilization systems and operating room protocol
• Directed timely documentation and reporting process for AAAHC accreditation and renewal
• Created analytical reports and projections for reimbursement, coding, equipment/supply management

Related Skills: Surgical Practices and Documentation, Statistical Data & Trend Analysis, Medical Equipment and Supply Management, Ambulatory Healthcare Accreditation, Electronic Medical Record Software, Practice Management Software, Customer Service

 

Research Assistant | Helen Wills Neuroscience Institute, Bao Laboratory

January 2011 – June 2011 | Berkeley, CA

• Assisted in the study of auditory perceptual changes in impacted murine subjects
• Managed data collection and stimulation procedures through LabVIEW and MATLAB

Related Skills: Animal Research Techniques & Training, Computational Data Collection and Analysis, Standard Laboratory Practices, MATLAB, LabVIEW

 

Technical Specialist and Graphic Designer | Emily's Bridal

January 2009 – March 2011 | Fremont, CA

• Established company brand identity and led website design and development

Related Skills: Adobe Photoshop, Adobe Illustrator, Web Design, Intuit Quickbooks, International Shipping, Customer Service

 

 

PROJECTS

Master's Project: Microfluidic Platform for Bacterial Biofilm Studies

June 2014 to Present

Experimental research involving the development and production of microfluidic device to culture and treat bacterial biofilms

 

 

Website and Online Portfolio: DANIELKHUC.COM

December 2008 to Present

Official site of Daniel Khuc and his engineering, design, and academic work

 

 

 

AWARDS AND RECOGNITION

  • Walter C. Benzing Fellowship (2014)
  • BCME Department Service Award (2014)
  • Intuitive Surgical SJSU Graduate Student Scholarship (2013)
  • UC Berkeley URAP Selected Scholar (2011)
  • South Bay Engineers Scholarship (2008)
  • Bank of America Achievement Award in Science & Math (2008)
 

ORGANIZATIONS

Regulatory Affairs Professionals Society (2016–Present)

San José State University Biomedical Engineering Society : SJSU BMES (2012–2014)

Tau Beta Pi Engineering Honor Society (2011)

  • Professional Development Officer (2011)

Cal Band (2008–2011)

 

INTERESTS

Graphic Design (2007–Present)

  • Print media, logo development, website structure, and digital illustration

Musical Performance (2000–Present)

  • Training in piano, organ, clarinet, and violin
  • Familiarity with guitar, drum kits, and choral singing
  • Performances with orchestral groups, marching bands, and other ensembles