Director, Quality

Position Summary

The Director, Post Market Quality leads the transformation of global strategy and operational execution for Clinical Evaluations, Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), and the integration of data sources that inform these activities.

 

Leading a team of data analysts and medical affairs professionals, the Director sets the strategic direction for global clinical and post-market initiatives, ensuring alignment with regulatory requirements and supporting technical documentation across the product lifecycle. The role also oversees planning and scheduling in collaboration with cross-functional partners to maintain compliance and operational efficiency. To enable scalability and innovation, the Director develops the strategy and drives the adoption of next generation automated solutions that enhance data utilization, streamline processes, and elevate enterprise-wide outcomes.

 

Key Responsibilities

• Lead strategic planning and transformation initiatives that elevate the effectiveness, scalability, and automation of Clinical Evaluation, PMS, and PMCF processes.
• Manage a cross-functional team of data analysts and clinical professionals focused on optimizing post-market regulatory deliverables and operational execution.
• Identify, evaluate, and deploy AI and automation technologies to improve efficiency, reduce manual workload, and drive standardization across global functions.
• Develop long-range roadmaps and process blueprints for post-market surveillance, data analytics, and clinical strategy aligned with global regulatory trends and business growth.
• Establish robust data-driven frameworks that enable proactive risk identification, smarter decision-making, and predictive compliance insights.
• Partner cross-functionally with Regulatory Affairs, Quality, R&D, Data Science, and IT teams to drive strategic alignment and cross-team integration.
• Serve as a thought leader on the use of digital tools and regulatory intelligence to optimize the post market surveillance activities.
• Monitor evolving global regulations, competitor strategies, and industry trends to ensure continuous innovation and readiness.
• Act as SME during regulatory audits, inspections, and senior leadership reviews, ensuring alignment of strategy with compliance expectations.

 

Leadership & Team Development

• Build and mentor a high-performing team with capabilities across data analytics, clinical strategy, and regulatory operations.
• Foster a culture of innovation, accountability, and continuous improvement within the Clinical Device function.
• Lead workforce planning and change management to support future growth and organizational readiness.

 

Qualifications

• Proven track record of strategic leadership in clinical, regulatory, or quality functions within the medical device, biotech, or pharmaceutical industry.
• Deep understanding of post-market regulatory frameworks (e.g., EU MDR, MEDDEV, MDCG, FDA PMS requirements).
• Strong systems thinking, business acumen, and ability to lead through complexity.
• Exceptional collaboration, influencing, and communication skills.

 

Education and Experience

• Bachelor’s degree required; advanced degree in science, engineering, data science, public health, or business strongly preferred.
• 13 years of industry experience, including 6+ years in a strategic leadership or transformation-focused role.
• Experience managing diverse, cross-functional teams including data professionals and domain experts.

 

Travel Requirements

• Up to 10% domestic and international travel may be required.

 

Work Environment

• Professional office environment.
• Standard office equipment usage.
• Occasional visits to healthcare or manufacturing sites may be required.

 

Physical Requirements and Work Environment 

• This is largely a sedentary role. 
• This job operates in a professional office environment and routinely uses standard office equipment.
• While performing the duties of this job, the employee may be required to si