Director, Regulatory Affairs

The role

The Director of Regulatory Affairs will build and lead the regulatory function and establish strategies for the company's IVD, NGS, and regulated life science instrumentation portfolio. This person will serve as a senior advisor to executive leadership and manage global regulatory strategies from development through lifecycle management.

What you will do

• Own and lead global regulatory strategy for IVD, NGS, software, and regulated life science instrumentation products
• Serve as senior Regulatory Affairs advisor to executive leadership and cross-functional teams
• Establish regulatory strategies early in product development
• Lead regulatory strategy and execution for global market authorizations
• Lead significant interactions with regulatory authorities and external stakeholders
• Establish regulatory strategy and responsibilities for diagnostic partnerships and collaborations
• Own regulatory assessment and governance for product, software, manufacturing, supplier, labeling, and lifecycle changes
• Provide regulatory leadership for post-market reporting obligations
• Establish regulatory governance, decision making, and escalation mechanisms
• Build and scale the Regulatory Affairs function

Required qualifications

• Minimum bachelor's degree in life sciences, engineering, regulatory affairs, or related discipline
• 12+ years of progressively responsible medical device or IVD Regulatory Affairs experience
• Substantial responsibility for regulated IVD product development, market authorization, and lifecycle management
• Demonstrated experience establishing regulatory strategy for complex diagnostic instruments, IVDs, molecular diagnostics, or similarly complex regulated products
• Experience leading regulatory programs across multiple major jurisdictions
• Demonstrated ability to advise senior executives and influence decisions without relying on positional authority
• Experience building or scaling a Regulatory Affairs function, team, operating model, or infrastructure
• Deep working knowledge of ISO 13485, ISO 14971, post-market requirements, labeling, change control, and applicable medical device/IVD regulatory frameworks
• Exceptional regulatory judgment
• Proven track record of working well cross functionally and in a collaborative way
• Self-directed, proactive, and embodies an enterprise mindset
• Ability to lift up to 20 pounds

Nice to have

• Advanced degree
• RAC
• Experience with FDA
• Experience with EU IVDR

Benefits

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

About the company

Element Biosciences is a product-driven organization committed to scientific integrity, collegiality, honesty, objectivity, and openness. Their mission is to empower the scientific community with more freedom and flexibility to accelerate collective impact on humanity.