Amit G.
NY
100% Job Success
Top Rated Plus
Ranked top 3% of all Upwork talent

Medical Device/Technology Professional - Quality & Regulatory Affairs

I am a skilled and experienced biomedical engineer specializing in the design and development of medical devices/medical technologies. I have worked in the medical technology industry for over a decade and have a Bachelors of Engineering and Masters of Science in biomedical engineering. With extensive expertise in design quality, quality assurance, and regulatory affairs within the industry, I am well-equipped to handle any challenges that may arise. Throughout my career, I have successfully worked with both large medical device corporations and startups, gaining invaluable insights into the FDA submission process and the specific requirements based on technology risk. I possess a thorough understanding of how to navigate the complex regulatory landscape and bring medical devices through the approval process. My previous accomplishments include the development and maintenance of robust quality systems, leading design quality projects for Class II/III medical devices by employing risk analysis and design control strategies. Additionally, I have extensive experience in interacting with the FDA throughout the pre-submission and 510(k)/PMA/De Novo submission processes, ensuring compliance and smooth communication. Furthermore, I am well-versed in auditing quality systems based on 21 CFR 820 and ISO 13485. This ensures that my clients can confidently rely on my expertise to meet and exceed regulatory requirements and industry best practices. If you are in need of a highly skilled MedTech consultant with a proven track record and in-depth knowledge of the medical technology industry, I am confident that my qualifications make me the ideal candidate for your project. Let's collaborate to bring your ideas to life and transform healthcare for the better.
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