Daniel Khuc

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

 

 

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)

 

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