Daniel currently serves as a regulatory collaborator on several medical device development teams at Varian Medical Systems. Along with the management of regulatory submission strategies and navigation of ever-changing regional market clearance pathways, Daniel has supporting expertise within many supporting areas of the product life-cycle, including product quality assurance, risk management, and post-market surveillance.

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, including AI-based device design and cybersecurity practices. His background experience also includes international travel for onsite consultation with engineering, risk management, and local regulatory teams, as well as fostering partnerships with business and marketing representatives to ensure the creation of compliant, impactful promotional campaigns.

EXPERIENCE

REGULATORY AFFAIRS MANAGER | VARIAN MEDICAL SYSTEMS

January 2020 – Present | Palo Alto, CA

• Oversee regulatory strategies and market clearance for SaMD products.

• Support business and technical initiatives in cloud migration, cloud infrastructure and AI/deep-learning developments.

• Engage with regulatory bodies and agencies for educational and regulatory feedback efforts.

• Develop regulatory structure and planning for global clearance strategies for SaMD products.

• Coordinate regulatory correspondence with governmental agencies, auditors, and standards organizations

Related Skills: 510k Submission Processes, AI/ML Regulatory Environment, Medical Device Software Design Lifecycle, 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

Regulatory Affairs Specialist | Varian Medical Systems

March 2015 – January 2020 | Palo Alto, CA

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

• Evaluate regulatory compliance of submission documents, product materials, design process records

• 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 license amendments/applications, CE Marking, Wireless Devices Standards, Cybersecurity Regulations, Complaint Handling, Promotional and Advertising Reviews, FDA and EU Regulations

Principal Organist and Musician | Irvington Presbyterian Church

2008 – 2017 | Fremont, CA

Project Developer | Precision SurgiCenter

2012 – 2014 | Fremont, CA

Research Assistant | Helen Wills Neuroscience Institute

2011 – 2011 | Berkeley, CA

Technical Specialist and Graphic Designer | Emily's Bridal

2009 – 2011 | Fremont, CA

EDUCATION

University of California, Berkeley

B.S. Bioengineering with Honors

Activities and Societies: 

California Marching Band, Tau Beta Pi Engineering Honor Society