Principal,RASpecialist

## Accountabilities Lead the preparation, authoring, and submission of global regulatory filings, including technical files, registrations, listings, and submissions required for product approvals. Collaborate with international regulatory counterparts to ensure timely and compliant submission of documentation across multiple global markets. Provide regulatory guidance and approval for design control deliverables, product development documentation, protocols, reports, and marketing materials. Assess regulatory risks and interpret evolving global regulations, ensuring alignment with corporate standards, SOPs, and applicable agency requirements. Support product development teams by ensuring regulatory requirements are integrated into design control, risk management, and lifecycle processes. Act as a subject matter expert on global IVD regulatory frameworks, providing strategic input on compliance, submissions, and regulatory pathways. Mentor and support junior and intermediate regulatory associates, fostering knowledge sharing and team development. Requirements: Bachelor’s degree in a technical or scientific field such as biology, biochemistry, chemistry, or related discipline. 7+ years of experience in a regulated industry, including at least 4+ years in global regulatory affairs within in vitro diagnostics (IVD). Strong knowledge of FDA and EU regulatory frameworks, including experience with PMA, 510(k), De Novo submissions, and technical documentation. Deep understanding of design control, risk management, and product development processes within regulated environments. Familiarity with ISO 13485, IVDR, and 21 CFR Part 820 requirements. Strong analytical, research, and problem-solving skills with the ability to manage multiple complex regulatory projects independently. Excellent communication and collaboration skills, with the ability to build consensus across global, cross-functional teams. Demonstrated ability to provide regulatory leadership and mentorship in a