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Tier-1 employer and metro location but niche medical-device regulatory skillset limits applicant density.
Role requires specialized medical-device regulatory and compliance expertise, limiting cross-industry portability.
Mandates specific medical-device regulatory expertise and compliance standards, creating strict screening filters.
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Lead and provide technical guidance in MDR development projects ensuring adherence to medical device regulatory standards.
Develop and mentor team members on 510(k) submissions, ISO 13485 compliance, and improve overall technical capabilities.
Manage process compliance, participate in technical reviews, and prepare status reports to minimize project risk and manage escalations.
Strong understanding of MDR processes and related regulatory requirements including 510(k), DHF, IVDR, and ISO 13485 standards.
Proficiency in implementing coding standards and best practices in medical device software development.
Work Experience Required: Not explicitly mentioned in the JD.
Excellent communication and leadership skills to guide and develop team members.
Experienced in leading technical teams within medical device regulatory projects focusing on MDR and 510(k) submissions.
Demonstrates expertise in quality and compliance standards (ISO 13485, DHF) influencing process adherence and risk management.
Capable of managing technical feasibility studies, architecture best practices, and project risk reporting in a medical device development environment.