Hsien Tang (Simon) Chen
San Diego, California, USA
Career Focus
Compliance, Regulatory Governance & Corporate Asset Oversight
Education
- MBA, UCLA Anderson Graduate School of Management (1986–1988)
- BA, National Taiwan University, Business Major (1978–1982)
Career Credentials
Medical Device Quality & Regulatory Compliance (FDA / ISO 13485), 2020 - 2025
Clients: Acutus Medical (Carlsbad, CA), Provisio Medical (San Diego, CA)
- Ensured manufacturing and assembly workflows complied with FDA QSR (21 CFR Part 820) and ISO 13485 standards
- Led QA and due diligence programs, including inspection protocols, process validation, and audit readiness
- Developed digital training and e-learning modules to reinforce compliance procedures and SOP adherence
- Supported documentation control, digital traceability, and regulatory compliance across device operations
Sales Force Conduct Compliance, 2007 - 2020
Clients: Pfizer (Beijing, China), Johnson & Johnson (Beijing, China), Novartis (Beijing, China), Eisai (Biogen) (Shanghai, China), Roche (Shanghai, China)
- Ensured alignment with anti-bribery, anti-kickback, and healthcare regulations (CFDA/NMPA)
- Defined compliant HCP engagement standards, including controls on improper inducements and documentation
- Partnered with Legal and Medical to implement compliance frameworks and digital training programs
- Integrated approved, evidence-based messaging into e-detailing tools for compliant execution
Message Delivery Compliance, 2000 - 2007
Clients: Johnson & Johnson Medical (Beijing, China), Medtronic (Shanghai, China), Boston Scientific (Shanghai, China)
- Designed digital training and e-learning programs to standardize sales calls and HCP interactions
- Ensured messaging adhered to approved indications and no off-label promotion
- Leveraged e-detailing tools to improve compliance, consistency, and auditability
- Strengthened monitoring and governance across cardiovascular products
Corporate Compliance & Financial Governance (1995 - 2000)
3G Cellular, Inc. – San Diego, CA
Officer of Administration & Legal Affairs
- Managed internal budget controls and financial governance
- Oversaw corporate legal matters including contracts and compliance
- Supported operational compliance through process controls
Promminent Communications, Inc. – San Diego, CA
Financial Controller & Legal Affairs Officer
- Directed budget planning and internal compliance processes
- Managed corporate legal functions and regulatory alignment
- Strengthened governance and audit readiness