Daniel Khuc

Daniel currently serves as a regulatory collaborator on several medical device development teams at Varian Medical Systems. These assignments consist of a diverse portfolio of products ranging from radiotherapy treatment planning software systems to sterilized titanium applicator components.

Along with the development of regulatory submission strategies and assessment of regional market clearance pathways, Daniel supports the execution of global and company-wide processes to help effectively fulfill the latest regulatory requirements while removing barriers to timely commercial distribution. By building and encouraging cross-functional communication, he has been able to design and secure several 510k and Health Canada clearances without incurring any review questions or holds on the presented content. 

Daniel actively participates in the healthy maintenance of regulatory understanding for various products, staying knowledgeable on the latest guidance for current issues facing the device industry. His background experience also includes international travel for onsite collaboration with engineering, risk management, and local regulatory groups, as well as fostering partnerships with marketing to ensure the creation of appropriate promotional materials containing medical device claims for Varian.

EXPERIENCE

REGULATORY AFFAIRS ANALYST | VARIAN MEDICAL SYSTEMS

March 2015 – Present | Palo Alto, CA

• Review and compile regulatory submissions for medical devices (510k submissions, Health Canada applications)
• 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