Director, Regulatory Affairs

📋 Description

• Own and lead Element's global regulatory strategy for IVD, NGS, software, and regulated life
• Serve as Element's senior Regulatory Affairs advisor to executive leadership and cross-functional
• Establish regulatory strategies early in product development, including intended use, claims
• Lead regulatory strategy and execution for global market authorizations, including the United
• Lead significant interactions with regulatory authorities, notified/assessment bodies, authorized
• Establish regulatory strategy and responsibilities for diagnostic partnerships, co-development

🎯 Requirements

• Minimum bachelor's degree in life sciences, engineering, regulatory affairs, or related discipline
• Typically, 12+ years of progressively responsible medical device or IVD Regulatory Affairs
• Demonstrated experience establishing regulatory strategy for complex diagnostic instruments, IVDs
• Experience leading regulatory programs across multiple major jurisdictions, including experience
• Demonstrated ability to advise senior executives and influence product, technical, clinical
• Experience building or scaling a Regulatory Affairs function, team, operating model, or

🎁 Benefits

• Stock options
• Discretionary annual bonus
• No cost health insurance plans
• 401k with company match
• Flexible paid time off