Isabela Monteiro
Regulatory Specialist at Aroa Biosurgery Limited
Based in Auckland, New Zealand
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Seniority
Staff
Department
Legal
Location
Auckland
Industry
Biotechnology Research
Company size
238
Contact information
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i•••••••@aroa.com
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Background
About Isabela Monteiro
A driven Regulatory Specialist with over 6 years of experience in the healthcare and medical device industries. At Aroa Biosurgery, I independently manage the company's PMS system and have successfully led complex country registrations across North America, Europe, South America, and the Middle East, including securing a 510(k) clearance, an EU MDR application, and acceptance into the FDA's STeP program. My expertise spans deep knowledge of ISO 13485 compliance, FDA, and EU MDR 2017/745 regulations. Prior to Regulatory Affairs, my 3 years as a Product Development Engineer at Fisher & Paykel Healthcare refined my skills in engineering innovative solutions for patient care. I am passionate about advancing medical device innovation and ensuring global regulatory excellence to positively impact patient outcomes.
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