

Meet Andre Butler
Andre has 25 years' Experience in Clinical, Regulatory, Product Development, Quality Working in various environments and a wide variety of product introductions.
- Participated in more than 50 clinical studies
- Managed a wide variety of Regulatory Submissions
- Submitted Drug, Device and Combination Products
- Managed various product mixes submissions, Class1, Class 2 and Class 3
- Managed a variety of product types: IVD, external Electrical, Active Implantable
- Constructed submissions for Registration, 510ks, IDEs, and PMAs
- Managed Large Concurrent Submissions
Past Responsibilities & Accomplishments:
Skill Sets:
- Certified Clinical Research Professional
- Certified Quality Auditor
- Regulatory Association of Professionals Contributor
- Technical File Expert
- Labeling and IFU Expertise
- Product Safety/ Serious Incident/ Field Safety Correction Action
- Post Market Surveillance