Sr Manager, Regulatory Affairs

We are looking for a Senior Manager, Regulatory Affairs to lead our US regulatory strategy and manage a dedicated team of regulatory professionals. Oversee complex regulatory submissions and ensure timely, compliant product launches. Ideal for experienced leaders with deep regulatory expertise in the medical device sector.

Skills

• us fda premarket approval
• us fda hud/hde for humanitarian use
• us fda section 520(b) custom device exemption
• us fda compassionate use
• us fda investigational device exemption
• us fda premarket notification (510(k))
• regulatory strategy
• regulatory reporting
• regulatory scheduling
• regulatory documentation
• regulatory process improvement
• regulatory compliance training
• regulatory labeling
• regulatory team leadership
• cross-functional collaboration
• stakeholder management
• microsoft word
• microsoft excel
• microsoft powerpoint
• microsoft outlook