Minimum of 10 years of progressive regulatory affairs experience in the medical device, diagnostics, or IVD industry.
Significant experience with FDA-regulated IVD products required.
Demonstrated leadership experience with FDA submissions, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, pre-submissions, and responses to FDA questions.
Prior experience leading regulatory strategy for product development, clinical validation, analytical validation, design changes, manufacturing changes, and post-market compliance.
Deep working knowledge of applicable regulatory frameworks, including FDA medical device and IVD regulations, PMA requirements, 510(k) requirements, 21 CFR 820/QMSR, ISO 13485, CLIA, IVDR, and relevant FDA guidance documents.
Advanced proficiency with Microsoft Word & Excel, and complex document formatting, including templates, styles, tracked changes, tables of contents, cross-references, and large technical documents.
Offices are reachable by elevator; must be able to climb stairs in the event elevator access is unavailable.
Ability to sit and/or stand and operate a computer and other technology-related equipment throughout the workday.
May occasionally enter laboratory or manufacturing areas and may be exposed to hazardous chemicals, biohazards, or related controlled environments, subject to applicable safety procedures.
Must be able to maintain confidentiality of proprietary, clinical, regulatory, and business-sensitive information.