Description
Join Epia Neuro as the Director of Regulatory Affairs in Alameda, California, driving the regulatory strategy for Class III implantable neurotechnology. Focus on major FDA approvals and cross-functional execution.
As the Director, you will be responsible for leading regulatory efforts and engaging with the FDA to achieve approval milestones. You'll work collaboratively with various departments, ensuring that the strategies are aligned with regulatory requirements while maintaining high standards for patient safety and outcomes.
Key Responsibilities:
• Lead regulatory communications and outcomes with agencies
• Develop global regulatory strategy from feasibility to approval
• Manage end-to-end regulatory submissions including PMAs
• Facilitate alignment among clinical, quality, and operational teams
• Guide regulatory direction and build necessary structures
Requirements:
• Advanced degree in life sciences or bio...
As the Director, you will be responsible for leading regulatory efforts and engaging with the FDA to achieve approval milestones. You'll work collaboratively with various departments, ensuring that the strategies are aligned with regulatory requirements while maintaining high standards for patient safety and outcomes.
Key Responsibilities:
• Lead regulatory communications and outcomes with agencies
• Develop global regulatory strategy from feasibility to approval
• Manage end-to-end regulatory submissions including PMAs
• Facilitate alignment among clinical, quality, and operational teams
• Guide regulatory direction and build necessary structures
Requirements:
• Advanced degree in life sciences or bio...
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