Rosalyn Cole Dincelli

Senior Vice President Global Clinical, Medical and Regulatory Affairs

Role: Senior Vice President Global Clinical, Medical and Regulatory Affairs at Establishment Labs
Location: Santa Barbara, CA, US
LinkedIn followers: 500 followers

About Rosalyn Cole Dincelli

Accomplished executive with strong medical device experience. Skilled in Aesthetic and Reconstructive Surgical, Medical Devices, Biotechnology, Injectables- toxin and fillers, MESH and ADM, U.S. Food and Drug Administration (FDA) PMA approval and commercialization and 510(k) Clearance. Global Studies, MDR transition, Med Affairs and Regulatory. Experience in business development diligence, pipeline strategy for organic and inorganic growth. Professional Education, Publication and KOL management with a focus on patient outcomes and surgical best practices.

Experience

Senior Vice President Global Clinical, Medical and Regulatory Affairs
Establishment Labs
Jan 2025 — Present

Education

Society of Clinical Research Associates
Certified Clinical Research Professional, Clinical/Medical Laboratory Science/Research and Allied Professions
UC Santa Barbara
BA, Communication and Marketing
1994 — 1998

Skills

Hardware Diagnostics
Plastic Surgery
Pharmaceutical Industry
Sop
Fda
Surgical Instruments
Regulatory Affairs
Operating Room
Orthopedic
Regulatory Submissions
Hospitals
CRO
Global Marketing
Gcp
Managed Care
Clinical Development
Disposables
Market Development
Edc
Therapeutic Areas
Ctms
Product Launch
Cardiology
Capital Equipment
Oncology
Urology
Surgeons
Pma
Cross-Functional Team Leadership
Biotechnology
Dermatology
Surgery
Project Management
Clinical Trials
Medical Devices
Clinical Research
Capa

Contact information

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Work email
r••••••••@establishmentlabs.com
Personal email
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Direct dial
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Current company

Establishment Labs

Medical Equipment Manufacturing · 977 employees · Alajuela, Costa Rica

Establishment Labs® (NASDAQ:ESTA) is a global medical technology company focused on improving patient safety and aesthetic outcomes, initially in the breast aesthetics and reconstruction market by designing, developing, manufacturing, and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at two FDA-compliant state-of-the-art facilities in Costa Rica and are currently approved for commercial distribution in over 70 countries through exclusive distributors or a direct salesforce. In March 2018, Establishment Labs® received approval for an investigational device exemption (IDE) from the FDA to initiate the Motiva Implants® clinical trial in the United States.

establishmentlabs.com

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