Senior Director - Regulatory Affairs

October 8

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Idea Evolver

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custom software development • medical device software • samd • content marketing • search engine optimization

11 - 50 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

💰 Non Equity Assistance on 2013-01

Description

• Serve as client facing, regulatory lead to bring SAMD products to the US market with FDA approval. • Provide regulatory expertise, guidance, and direction, inclusive of potential risks and strategic opportunities, to regulatory affairs and cross functional leadership. • Evaluate proposed product modifications for regulatory impact and completing regulatory assessments. • Driving regulatory compliance for successful FDA 510(k) submissions. • Supporting RA specialists in preparation and submission of 510(k)s, including any follow up and Note to Files. • Supporting Business Unit regulatory affairs teams to interact with FDA in support of ACNU clearance activities. • Overseeing QA/RA team to provide support for ensuring company compliance with all applicable quality, regulatory, & statutory requirements. • Serving as Management Representative leading and promoting company initiatives in support of Idea Evolver’s Quality Policy and Objectives through continuous improvement of the Quality Management System (QMS) and associated records. • Overseeing CAPA, Change Management, Internal and External Audits, Management Review & Post-Market Surveillance needs. • Ensuring the organization is meeting regulatory and quality objectives. • Responsible for ensuring compliance to Design Control & SDLC process requirements at a project level. • Serving as the main contact between Idea Evolver and customer to support regulatory submissions, communications with the FDA and supporting audits. • Maintaining current knowledge of the development and changes to applicable laws, regulations and industry standards for the US and assist in the dissemination of this information. • Ensuring cross-functional teams receive communication regarding project milestones to support their daily work. • Interfacing with appropriate internal and external resources to ensure on-time delivery for project and accurately communicate project risks, impacts and mitigation. • Leading teams in preparation for Phase Gate Reviews and decisions.

Requirements

• 10+ years of experience in Regulatory and Quality management, preferably in the SaMD space. • ACNU expertise is a huge bonus. • Sophisticated understanding of cloud-based software. • Understanding of regulatory implications of machine learning models. • Experience working with medium to large-sized businesses in a client-facing role. • Highly motivated, independent individual with strong organizational skills and a thorough attention to detail. • Strong analytical and problem-solving skills with the ability to make data-driven decisions. • Excellent written and verbal communication skills, with the ability to present complex ideas in a clear and concise manner. • A proven track record of delivering successful products on time and within budget. • Bachelor’s degree required.

Benefits

• Competitive Salary • Health and wellness benefits • 401k with company matching • 20 paid days off plus holidays