Tabitha B.
Regulatory Affairs Specialist II In-Direct Markets - LATAM, EMEA, APAC
- Role
- Regulatory Affairs Specialist Ii at Candela Medical
- Location
- Greenville, NC, US
- LinkedIn followers
- 500 followers
About Tabitha B.
I am a Regulatory Affairs Specialist II with hands-on experience supporting global medical device registrations across LATAM, APAC, and EMEA markets. At Candela Medical, I manage international submissions, coordinate with distributors, and contribute to compliance activities including MDSAP audit documentation and preparation.Skilled in ANVISA submissions, BGMP (Brazilian Good Manufacturing Practices), and INMETRO certification processes, with hands-on involvement in both regulatory submissions and audit readiness for Brazilian market access for Class II and Class medical devices.Currently expanding my expertise in the EU MDR transition process, gaining in-depth knowledge of evolving European regulatory requirements and their impact on global market access.Based in the U.S, I also serve on the RAPS Brazil Chapter Leadership Team, helping to strengthen community engagement, drive professional development, and foster collaboration among Brazilian regulatory professionals.I am passionate about navigating complex regulatory frameworks, supporting innovative medical technologies, and advancing global patient safety.
Experience
Regulatory Affairs Specialist Ii
Apr 2025 — Present
Education
East Carolina University
Bachelor of Science in Business Administration - BSBA, Marketing
2017 — 2018
East Carolina University
Master of Business Administration - MBA, International Management
2019 — 2020
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