Regulatory Affairs Specialist II - RemoteFull-Time 37.5 Hours per WeekMy client is a leading provider in the diagnostics industry, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing. Their work provides critical information for the treatment and management of diseases and other health conditions.We are currently seeking a Regulatory Affairs Specialist II within the Infectious Disease business unit. In this role, you will be responsible for preparing documentation for international product registrations.This job description will be reviewed periodically and is subject to change by management.Responsibilities:Prepare technical documentation in accordance with In Vitro Diagnostic Medical Device Regulation (IVDR).Provide regulatory support for diagnostic product development and commercial diagnostic products.Perform regulatory impact assessments to ensure compliance with international regulations and timelines.Coordinate with internal and external stakeholders to gather necessary information.Maintain up-to-date knowledge of regulatory changes and industry standards.Develop regulatory strategies for new and modified products to achieve international clearance/approval.Support regional regulatory teams with submissions, license renewals, and amendments.Research and communicate scientific and regulatory information to support submission documents.Compile and publish all material required for submissions, renewals, and annua