Associate Regulatory Affairs, Human Health Diagnostics

Job Description: • Prepare, review and submit regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files) • Ensure compliance with FDA, EU IVDR, and other international regulatory requirements • Utilize checklist, symbol standards, and regulatory guidances 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 global regulatory impact Requirements: • Minimum of BS/BA in relevant discipline • 3-5 years direct human health IVD experience and/or minimum 8 years of direct non-IVD human health regulatory experience • Direct experience with 510(k)/CLIA waiver application experience • Preferred: knowledge of SAP, Veeva Vault and Trackwise • Strong verbal and written communication and organizational skills • High level of competency using Microsoft Office suite, Microsoft Word and Excel and Adobe Acrobat • Able to effectively communicate in English with colleagues at all in various levels of the organization • Attention to detail to ensure all expectations for labels are met • Flexibility and capacity to handle multiple tasks at once • Demonstration of a highly effective and deeply committed team player • Consistently models behaviors of accountability, approachability, and ownership • Ability to work independently, while fostering good working relationships across physical distance • Capable of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment • Passionate and Enthusiastic • Demonstrates “can do” energy and follow through. Benefits: • Excellent full time benefits including comprehensive medical coverage • Dental and vision options • Life and disability insurance • 401(k) with company match • Paid vacation and holidays • Yearly goal-based bonus & eligibility for merit-based increases Apply tot his job