Camille Fleischer
- Role
- Senior Regulatory Affairs Specialist at Smith Nephew
- Location
- Nashua, NH, US
- LinkedIn followers
- 500 followers
About Camille Fleischer
A strongly reliable and focused Regulatory Affairs professional with a Master’s in Global…
Experience
Senior Regulatory Affairs Specialist
May 2021 — Present
Develop global Regulatory strategies including but not limited to US, Europe, Canada, Australia, and China. • Collaborative engagement with International Regulatory team to define pathways forward for global registration. • Implementation and management of Technical File review schedule. • Provide regulatory guidance and feedback throughout product development lifecycle including input on testing requirements, standards, and labeling requirements. • Write 510(ks), Letters-to-File, Class II and Class Medical Device License Applications, EU MDD Technical Files (Class I, Class IIa, Class IIb, and Class products), EU MDD Design Dossiers, and EU MDR Class Technical Documentation Dossiers. • Program management of post market approval change implementation. • Assess impact of Engineering Change Requests (ECR) on existing registrations and completing the identified regulatory submissions to support the change. • Communicate with regulatory agencies and Notified Bodies. • Subject matter expert during Technical File and MDSAP audits. • Review promotional materials to insure compliance with both domestic and foreign government regulations. • Maintain working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and import/export requirements.
Education
Gettysburg College
Bachelor’s Degree, Psychology
2010 — 2014
The George Washington University
Master of Science - MS, Global Regulatory Affairs
2015 — 2017
Skills
- Powerpoint
- Social Networking
- Good Documentation Practices (Gdp)
- Lotus Notes
- Microsoft Excel
- Microsoft Office
- Microsoft Powerpoint
- Fundraising
- Time Management
- Certificates of Pharmaceutical Product (Cpp)
- Spss
- Public Speaking
- Leadership
- Research
- Social Media
- Master Control
- Analysis
- Microsoft Word
- Outlook
- Deviations
- Cgmp Practices
- Spl
- Corrective and Preventive Action (Capa)
- Creative Writing
- Community Outreach
- Event Planning
- Customer Service
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