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We transcend the technological gap and tailor our systems to be compatible with how the medical industry works today
You will own the Regulatory area at Powerful Medical. You will ensure proper compliance and alignment with regulatory standards for our already certified products and lead the certification of new ones. For this important role, we are looking for a seasoned professional, experienced with both MDR and FDA, who wants to impact one of the most important shifts in modern medicine.
5+ years of experience in regulatory affairs and quality management
Biomedical, clinical or software engineering (or equivalent scientific discipline) to degree level
In-depth knowledge of the US FDA and EU MDR regulatory landscape
In depth knowledge 21 CFR 820, IEC 62304, ISO 62366-1, ISO 13485, and ISO 14971.
History of successful 510(k), De Novo's, IDE, and/or PMA device submissions. Other worldwide submissions and clearances are a plus.
Experience with new product development projects for software as a medical device (SaMD) or medical device component. Ability to review and provide critical feedback on design documentation.
Excellent command of the English language
Ability to communicate and interact with regulatory agencies and consultants
Excellent project management skills
Experience in growing and managing high-performing and multi-disciplinary teams
Display, encourage, and inspire a culture of excellence across the entire organization
Nice to have
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