Description:
The Senior Director of Global Customer Advocacy (Post-Market Surveillance) is responsible for leading the company’s global complaint handling and post-market surveillance programs, ensuring product safety, regulatory compliance, and customer satisfaction. This role drives strategic oversight of adverse event reporting, vigilance, and trend analysis, while partnering cross-functionally with Quality, Regulatory, Legal, Clinical, Medical Affairs, Engineering, and Operations to resolve key product issues. Leveraging data analytics, industry best practices, and scalable systems, the Senior Director ensures efficient, compliant processes that support continuous improvement and align with global regulatory requirements.
Where You Come In
- Strategic Leadership & Oversight
- You will define and execute global strategy for complaint handling and post-market surveillance across multi-site, multi-country operations.
- You will develop departmental strategic plans aligned with global regulations and corporate initiatives.
- You will own and manage departmental budget and capital spending plans.
- You partner with executive leadership to establish and maintain strategic objectives.
- Team Management & Development
- You lead, mentor, and develop multi-level, geographically dispersed teams.
- You ensure staffing, training, and performance management support operational excellence.
- You promote a strong understanding of the Quality Management System (QMS), global regulatory requirements, and data privacy laws.
- Cross-Functional Collaboration
- You collaborate with Quality, Regulatory Affairs, R&D, Medical Affairs, Engineering, Operations, Legal, and Customer Service to resolve product issues and improve customer satisfaction.
- You actively contribute to product design and risk management teams.
- You participate in the Quality Action Committee for key risk management decisions.
- Regulatory Compliance & Reporting
- You ensure complaint handling and reporting processes comply with global regulations (FDA, EU MDR, ISO 13485, etc.).
- You communicate directly with global regulatory authorities regarding product complaints and trends.
- You support Internal and External Audit Activities.
- You oversee identification and reporting of potentially reportable events to regulatory agencies.
- Data Analytics & Continuous Improvement
- You leverage data analytics to identify trends, risks, and improvement opportunities.
- You monitor global data to detect emerging issues and evaluate effectiveness of corrective actions.
- You drive digitalization and process simplification to enhance efficiency and scalability.
- You translate customer feedback into actionable insights for product and process improvements.
- Performance Monitoring & Governance
- You establish departmental metrics, goals, and service level agreements (SLAs).
- You report key performance indicators (KPIs) to executive leadership.
- You ensure follow-up and corrective actions when SLAs or metrics are not met.
What Makes You Successful
- Proven experience leading global teams in complaint handling, post-market surveillance, or related quality/regulatory functions.
- Deep understanding of global regulatory requirements and standards (FDA, EU MDR, ISO 13485, etc.).
- Strong analytical skills with experience in high-integrity, data-driven decision-making.
- Excellent communication and leadership abilities.
- A minimum of 8-10 years of experience in complaint vigilance and quality assurance within the medical device / biotechnology industry.