IDEA EVOLVER · 2 months ago
Senior Director of Regulatory Affairs
United States
Full-time
Remote
Director/Executive
10+ years expIDEA EVOLVER is a Consumer Healthcare Technology and Pharmaceutical Launch Partner dedicated to accelerating safe access to life-changing treatments. They are seeking a highly motivated and experienced Senior Director of Regulatory Affairs to drive regulatory strategy and execution of innovative products in the Software as a Medical Device space.
AdvertisingAnalyticsConsultingMarketing
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
Qualification
Required
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
Company
IDEA EVOLVER
Idea Evolver is a company that provides online marketing strategy, technology development, data analysis, and brand design.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2013-01-01Non Equity Assistance
Leadership Team
Shawn D.
Chief Executive Officer
Ryan Underwood Wall
Co-founder/CMO
Recent News
2023-12-22
Company data provided by crunchbase