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 impactRequirements:• 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