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
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Apply Now