Manager of Regulatory Affairs lead/manage complex issues with multiple competing priorities that have a direct impact on site operations and opportunities. Will develop strategies for approvals worldwide advise on regulatory requirements and prepare submissions and facilitate their approval.
Manage regulatory challenges (adverse events) related to development manufacturing and commercialization and recommend solutions and effect resolution. The position reports to the VP of QA/RA and manages a staff of 4 people as well as managing projects. The individual will also facilitate CAPA system and lead internal audit programs.
Must have 5+ years with medical device class II (or higher) or pharmaceutical within the regulatory environment. Experience with PMA and 510(k) is required. Must also have solid knowledge and experience with CFRs MDD MHW Ordinances etc. Highly desirable is certification in Regulatory arena: RAPS or ASQ or other
• EDUCATION: BS is required in a technical or scientific discipline.