Jennifer Mateus
Vice President, Regulatory, Quality & Clinical Affairs at Q\'apel
- Role
- Vice President, Regulatory, Quality & Clinical Affairs at Q\'apel at Q\'apel Medical
- Location
- Eugene, OR, US
- LinkedIn followers
- 500 followers
About Jennifer Mateus
Regulatory Affairs professional with over 20 years medical device experience. Specialized experience with Class medical device/drug combination implants. Excellent understanding of global quality and regulatory requirements. Expertise in audits and inspections.Specialties: Creative regulatory strategy development, establishing clear, comprehensive regulatory submission requirements, ensuring timely submission and approval. Knowledgeable of vascular products: bioresorbable coronary scaffold systems, drug eluting coronary stent systems, coronary stent systems, coronary dilatation catheters, coronary guidewires, endovascular stent systems, endovascular dilatation catheters, endovascular guidewires, closure devices, and a wide variety neurovascular products and accessories.
Experience
Vice President, Regulatory, Quality & Clinical Affairs at Q\'apel
Apr 2025 — Present
Education
San José State University
Bachelor of Science, Mass Communication - Journalism, Minor in Political Science
1991 — 1995
Skills
- Clinical Development
- CRO
- Commercialization
- Vascular
- Cross-Functional Team Leadership
- Iso 14971
- Gmp
- R&D
- Ctms
- Sop
- Fda
- Auditing
- Corrective and Preventive Action (Capa)
- Ce Marking
- Medical Devices
- Clinical Research
- Capa
- Premarket Approval (Pma)
- Design Control
- 21 Cfr Part 11
- Regulations
- Regulatory Submissions
- Combination Products
- Quality System
- V&V
- Drug Eluting Stents
- Regulatory Requirements
- Data Analysis
- Regulatory Affairs
- Clinical Trials
- U.s. Food and Drug Administration (Fda)
- Catheters
- Quality Assurance
- Pma
- Iso 13485
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