Remote Senior Director of Regulatory Affairs

Summary

Join our dynamic and growing team as a Senior Director of Regulatory Affairs to drive regulatory strategy and execution of innovative products in the Software as a Medical Device space.

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

Responsibilities

• 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

Benefits

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