The primary duties involve performing all work in compliance with company quality procedures and standards. This includes assessing reportability for global and regional events, drafting and submitting adverse event reports, and completing field action tasks. The role requires staying informed of global vigilance reporting and field action regulations, advising external stakeholders, and representing the vigilance and/or field action function on cross-functional project teams. Responsibilities also include drafting and owning departmental procedures, completing quality updates, and managing improvement projects to support continuous improvement within the organization. A Bachelor's degree in a related scientific field with a minimum of 7 years of experience, or a Master's with 6 years, or a PhD with 4 years of experience is required. Additionally, at least 7 years in regulatory affairs or a similar regulated industry, with a preference for the medical device/IVD industry, and 4 years of project leadership experience are necessary.