POSITION SUMMARY:
We are seeking an experienced Regulatory Affairs Associate to support our Human Health and Animal Health Diagnostics Groups, specifically focused on regulatory submissions and compliance. This role is ideal for a detail-oriented professional with a strong understanding and experience of global regulatory requirements and a passion for ensuring patient safety.
JOB DUTIES include but are not limited to:Assist with preparing and review of regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files).Ensure compliance with FDA, EU In Vitro Diagnostic Device Regulation, and other international regulatory requirements and appropriate regulatory requirements are provided to support global registrations.Utilize checklist, symbol standards, and regulatory guidance’s to ensure label compliance with FDA and global regulatory expectations.Collaborate with business partners to assure timely review, approval and processing of regulatory documents.Utilize systems for entry and tracking of regulatory activities.Manage and communicate accurate timelines for deliverables.Assess product changes for potential global regulatory impact.Collaborate with the cross-functional development teams to ensure regulatory project needs are met.
