Sharon Bianco
- Role
- Senior Regulatory Affairs Specialist - Permanent Role at LeMaitre
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
Healthcare & Human ServicesView LinkedIn profile
About Sharon Bianco
Industry professional with a strong scientific and analytical background. Five plus…
Experience
Senior Regulatory Affairs Specialist - Permanent Role
Aug 2019 — Present
Completed technical documentation in support of regulatory registrations in the European Union [EU MDR (class IIa, IIb, and class medical devices)]. Completed Regulatory registrations and approvals in Canada, Australia and International submissions in China, Japan and additional geographies in Asia Pacific (APAC).
Skills
- Chemistry
- Elisa
- Clinical Research
- Fda
- Capa
- Medical Devices
- Quality Control
- Clinical Trials
- Validation
- V&V
- Iso 13485
- Technical Writing
- Software Documentation
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