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

• 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

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.

• Regulatory Affairs Experience
• FDA Regulations Knowledge
• Regulatory Affairs Certification (RAC)
• Medical Device Industry Experience
• Product Lifecycle Management

• Regulatory Strategy Development
• Regulatory Compliance Requirements
• Risk Mitigation Strategies
• Project Management
• Regulatory Due Diligence

• Stakeholder Influence
• Collaboration
• Analytical Thinking
• Communication

• Regulatory Affairs Certification (RAC)

• FDA-Regulated Industry
• Medical Device
• Mergers and Acquisitions (M&A)
• Product Development
• Commercialization