Principal Regulatory Affairs Specialist

Partner with Business Development teams to support regulatory and quality due diligence for potential acquisitions Research and analyze new technologies, business models, product portfolios, and regulatory landscapes for strategic decision-making Lead regulatory strategy development and execution for product development, commercialization, and lifecycle management Collaborate on integration planning following acquisitions Serve as a regulatory subject matter expert on significant projects Provide guidance on regulations, standards, and compliance requirements Monitor global regulatory changes and communicate impacts, risks, and required actions Evaluate regulatory risks and develop mitigation strategies Review project progress and regulatory deliverables Recommend procedural improvements to enhance compliance and efficiency Translate complex regulatory requirements into actionable project plans and compliance activities Requirements Bachelor's degree required Degree in Engineering, Biological Sciences or equivalent focus preferred Minimum 8 years of relevant Regulatory Affairs/Quality Assurance experience within an FDA-regulated industry Applied knowledge of FDA regulations and regulatory compliance requirements Regulatory Affairs Certification (RAC) preferred Master's degree in Regulatory Affairs or related discipline preferred Medical device industry experience strongly preferred Experience supporting products throughout the full product lifecycle, including product development, commercialization, post-market activities, and lifecycle management Experience supporting business development, due diligence, mergers and acquisitions (M&A), licensing activities, or other strategic business initiatives preferred Ability to assess regulatory and quality risks, navigate ambiguity, and influence stakeholders across complex organizations Core Competencies Demonstrates expertise in Regulatory Affairs and Quality Assurance within FDA-regulated industries, with a strong focus on compliance, risk assessment, and strategic decision-making throughout the product lifecycle. Highest-signal resume keywords Regulatory Affairs Experience FDA Regulations Knowledge Regulatory Affairs Certification (RAC) Medical Device Industry Experience Product Lifecycle Management ATS Optimization Keywords Hard Skills Regulatory Strategy Development Regulatory Compliance Requirements Risk Mitigation Strategies Project Management Regulatory Due Diligence Soft Skills Stakeholder Influence Collaboration Analytical Thinking Communication Certifications & Qualifications Regulatory Affairs Certification (RAC) Industry Keywords FDA-Regulated Industry Medical Device Mergers and Acquisitions (M&A) Product Development Commercialization #J-18808-Ljbffr