Eliza Wang
Associate Director, Global Regulatory Affairs, Medical Devices, IVDs, Combination Products, and Digital Health Products at Alexion, AstraZeneca Rare Disease Unit
- Role
- Associate Director, Gra Devices, Genomic Medicine, Samd and Combination Products at AstraZeneca
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Eliza Wang
12+ years of regulatory affairs experience including: Combination Products, SaMD (Software as Medical Device), IVD, and Medical Devices. Key words: Global Regulatory Submission, Regulatory Strategy, HA Interactions and HA Inquiries, Product Lifecycle Management.Regulatory Affairs Certification (RAC)(Global) from RAPS.Certified Medical Device Regulatory Affairs from RAPS. Pre-market and post-market requirements. Combination Products, SaMD, QSR and GMP. IVD regulations. MDD. Bilingual (English, Mandarin).Specialties: BLA, NDA, IND, 510(k)s, EU Design Dossier and Tech File, PMA Pre-Submission, Health Canada License Application, China SFDA registration, Japan Shonin/STED, South American registrations.Certificate of ISO 13485:2003 Auditor, Lead Auditor
Experience
Associate Director, Gra Devices, Genomic Medicine, Samd and Combination Products
Apr 2024 — Present · Boston, MA, US
Education
SUNY New Paltz
MBA, Finance
RAPS
Certificate, Medical Device Regulatory Affairs
2009 — 2010
Skills
- Medical Devices
- Regulatory Affairs
- Qsr
- Gmp
- 510 K
- Strategy
- Iso 13485
- Clinical Research
- Quality System
- Fda
- Regulatory Submissions
- Pma
- Regulatory Requirements
- V&V
- Capa
- Validation
- Biotechnology
- Pharmaceutical Industry
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