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
