Senior Director of Regulatory Affairs - Remote

Overview

The Senior Director of Regulatory Affairs is responsible for leading the regulatory strategies for Dispensing and Pharmacy Automation Platforms, ensuring compliance and effective stakeholder engagement while driving innovation in the Medication Management Business Unit.

In Short

• Lead the Regulatory Affairs team for Dispensing and Pharmacy Automation.
• Develop regulatory strategic roadmaps and provide leadership for domestic and international programs.
• Ensure alignment of regulatory strategies with business objectives.
• Manage relationships with regulatory agencies and Notified Bodies.
• Oversee the preparation of product information for registrations.
• Conduct training on regulatory issues for staff and stakeholders.
• Assess resource requirements and manage a diverse team.
• Travel up to 30% for regulatory engagements.
• Engage in negotiations with regulatory agencies.
• Promote a culture of learning and development within the team.

Requirements

• M.S. degree in a technical discipline; advanced degree preferred.
• Minimum ten years of experience in regulatory affairs in the medical device field.
• Seven years of management experience.
• Strong negotiation skills with regulatory agencies.
• Ability to resolve problems and make decisions under pressure.
• Demonstrated project management and communication skills.
• Proven management skills of multicultural teams.
• Current knowledge of global regulations and quality systems.
• Strong business acumen and customer focus.
• Ability to conduct training and develop competencies in staff.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Supportive work environment that values contributions.
• Commitment to employee well-being.
• Inclusive culture that encourages authenticity.