Director of Regulatory Affairs & Patient Safety - Remote

Overview

The Director, Regulatory Affairs & Patient Safety is responsible for managing the Enterprise Quality Management approach to regulatory intelligence while focusing on patient safety in a dynamic healthcare environment.

In Short

• Lead regulatory compliance and patient safety initiatives.
• Enhance pharmacovigilance oversight and compliance.
• Analyze trends to improve performance in pharmacovigilance operations.
• Navigate the regulatory landscape and ensure compliance.
• Oversee product recall processes and quality review board activities.
• Drive a culture of quality and compliance within the organization.
• Collaborate with business units on investigations and corrective actions.
• Support licensing team capabilities and processes.
• Participate in REMS program management and compliance.
• Ensure effective communication and training regarding regulatory requirements.

Requirements

• Bachelor’s or advanced degree in a healthcare-related field preferred.
• 10+ years of experience in healthcare or pharmaceuticals.
• Proven leadership and coaching skills in a matrixed environment.
• Strong problem-solving and business acumen.
• Knowledge of quality improvement tools like Six Sigma and Lean.
• Excellent communication and organizational skills.
• Ability to manage multiple projects simultaneously.
• Experience with regulatory compliance and quality assurance standards.
• Authorization to work in the US required.
• Sponsorship is not available for this position.

Benefits

• Competitive compensation package.
• Annual bonus and long-term incentive opportunities.
• Comprehensive benefits including health and wellness programs.
• Opportunities for professional growth and development.
• Inclusive and diverse work environment.
• Supportive company culture focused on employee well-being.