Senior Director - Regulatory Affairs

Job not on LinkedIn

April 3

Apply Now

Receive Emails with Similar Jobs

Idea Evolver

WebsiteLinkedInAll Job Openings

Data • Artificial Intelligence • Healthcare Insurance

Idea Evolver is a company that provides global commercial solutions for FDA-regulated companies. They specialize in discovering commercial insights through comprehensive search behavior analysis and strategically position brands across the search and generative AI landscape. The company also pioneers over-the-counter (OTC) options for drugs that require more than labeling changes, ensuring optimal brand and trial positioning within the search and generative AI continuum.

11 - 50 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

💰 Non Equity Assistance on 2013-01

📋 Description

• Join as Senior Director of Regulatory Affairs for Software as a Medical Device. • Drive regulatory strategy and execution for innovative products. • Define regulatory requirements and policies. • Serve as client-facing regulatory lead for FDA approval. • Provide regulatory expertise and guidance to teams. • Evaluate product modifications for regulatory impact. • Ensure successful FDA 510(k) submissions and compliance. • Oversee QA/RA teams for quality and regulatory compliance. • Interface with internal and external resources for timely project delivery.

🎯 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