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Global Regulatory Affairs Manager – Biologics & Devices
Job in
High Point, Guilford County, North Carolina, 27264, USA
Listed on 2026-08-15
Listing for:
Dormont Manufacturing Co
Full Time
position Listed on 2026-08-15
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Bioventus is seeking a Regulatory Affairs Manager in the United States to lead global regulatory strategies and submissions for biologics products. You will collaborate with R&D, Engineering, Quality, and Operations to ensure compliance and timely approvals.
The role requires 5–7 years in regulatory/quality submissions, strong knowledge of FDA regulations, and experience with Class II devices or PMA/BLA/NDA processes. Excellent communication and coordination skills are essential.
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