Director Complaint Vigilance – Medical Device

Retained Search

Overview: My client, a leading innovative medical device company, seeks a highly experienced and motivated individual to join its team as the Director of Complaint Vigilance.

Responsibilities:

• Lead and manage the Complaint Vigilance department, ensuring compliance with global regulatory requirements.
• Develop and implement strategies for handling product complaints, including investigation, reporting, and corrective actions.
• Oversee the monitoring and trending of complaint data to identify potential product issues and implement preventive measures.
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Product Development, to ensure alignment on vigilance activities.
• Maintain up-to-date knowledge of industry standards and regulatory requirements for medical device vigilance.
• Prepare and present reports to senior management on vigilance activities and key performance metrics.

Qualifications:

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering). Advanced degree preferred.
• A minimum of 8-10 years of experience in complaint vigilance and quality assurance within the medical device industry.
• Proven leadership experience with a track record of managing teams and complex projects.
• In-depth knowledge of global regulatory requirements for medical device complaint vigilance, including FDA and EU MDR regulations.
• Strong analytical skills and the ability to interpret complex data.
• Excellent communication and interpersonal skills.

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