Title: Director of Regulatory Affairs

Salary : $190,000 to $220,000

Summary:

A leading medical device client of ours is looking to add a passionate and experienced Director of Regulatory Affairs to their team based out of Aliso Viejo, California. This client is a leading ophthalmology innovator, committed to improving patient care. The main function of the Director is to collaborate in the development and implementation of world-class regulatory programs and contribute their expertise of FDA and EU regulations. This role will give you a great opportunity to make an impact at a revolutionary company and help them fulfill their mission of revolutionizing the cataract surgery experience.

The Director will be responsible for…

• Preparing international regulatory submissions and FDA submissions, including Technical Documents, Technical Files, Device License Applications and Amendments, and Premarket Approvals (PMAs)
• Acting as a subject matter expert in regulatory affairs, offering training and guidance to team members as necessary
• Possessing a comprehensive understanding of medical device regulatory requirements, including FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), ISO standards (e.g., ISO 13485, ISO 14971), and international regulatory frameworks
• Participating in cross-functional project teams and serve as a global regulatory advisor

The Director should have the following qualifications:

• Bachelor’s or Master’s degree
• 7 to 10 years of regulatory affairs experience within the medical device industry
• Extensive experience with premarket regulatory activities in the US, EU, and other global markets
• A “hands-on” approach that fosters a strong, cohesive, team-oriented work environment
• Proven track record of success in achieving and maintaining high-quality standards.