Regulatory Affairs Manager - IVD

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory pathways. The position will work closely with R&D, Clinical Affairs, Quality, Manufacturing, Product Management, and external partners throughout the product development lifecycle.

What You Will Do

Develop and execute U.S. regulatory strategies for new and existing IVD products, determine appropriate regulatory pathways, and provide regulatory guidance to R&D, Clinical, Quality, Manufacturing, and Product teams throughout product development.

Why It Might Be a Fit

The ideal candidate has at least five years of regulatory affairs experience in the IVD or medical device industry, with hands-on experience preparing FDA submissions and interacting with FDA.

Requirements

• Bachelor’s degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory Science, Regulatory Science, Life Sciences, or a related scientific discipline.
• Minimum 5 years of Regulatory Affairs experience in the IVD, medical device, diagnostics, or related regulated healthcare industry.
• Hands-on experience preparing and supporting FDA regulatory submissions.
• Strong knowledge of FDA medical device and IVD regulatory requirements.
• Experience reviewing technical documentation, analytical performance studies, clinical performance data, and product labeling.
• Demonstrated ability to manage regulatory projects independently and work effectively across multiple functions.
• Excellent technical writing, analytical, organizational, and communication skills.
• Ability to manage multiple regulatory projects and deadlines simultaneously.

Benefits

• Comprehensive medical insurance.
• 401(k) plan with generous company contributions.
• Flexible paid time off (PTO) policy.