Global IVD Regulatory Lead — FDA/HC/EU Submissions

A leading biotechnology company is seeking a Principal Regulatory Affairs Specialist in San Diego, CA to support global regulatory strategies for in-vitro diagnostic products. The role involves managing submissions to FDA and Health Canada, collaborating with design teams, and developing regulatory strategies. Candidates should have a Bachelor's degree in a scientific field and over 8 years of experience in Regulatory Affairs, specifically in medical devices with a focus on IVD. Strong experience with submissions and regulatory compliance is required.
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