Sr./Director, Regulatory Affairs

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Requirements:

• 15+ years of experience in regulatory affairs management
• Knowledge of FDA regulations and ISO standards
• Proven ability to lead regulatory initiatives
• Familiarity with QMS software and regulatory submission platforms
• RAC or similar certification is a plus

Responsibilities:

• Lead efforts for FDA submissions and approvals
• Develop regulatory strategy for product pipeline
• Collaborate with R&D and clinical teams for compliance
• Support audits and inspections
• Provide training on regulatory requirements