Hybrid Director, Post-Market Surveillance, Clinical Evaluation

at Cook Group

• Job title: Director, Post-Market Surveillance, Clinical Evaluation
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Bloomington, United States

About the role

• Director leading global strategy for Post-Market Surveillance and Clinical Evaluation at Cook Medical Holdings. Inspiring teams to ensure regulatory compliance and continuous improvement in medical device operations.

Responsibilities

• Direct and maintain a scalable, global structure for PMS & CE ensuring clear communication and alignment with regional regulatory needs and business objectives.
• Develop and lead strategic vision and objectives for the global PMS & CE team, ensuring alignment with overall corporate goals, regulatory requirements, and operational excellence initiatives.
• Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies.
• Provide leadership and mentorship and technical expertise to a diverse, geographically dispersed PMS and CE team, ensuring alignment with global standards and regional needs.
• Oversee and manage PMS & CE budgets, including cost tracking, and strategic planning to support global operational priorities.
• Oversee and ensure that all PMS & CE activities comply with applicable regulations, including FDA (21 CFR Part 801, 21 CFR Part 820), EU MDR/IVDR (Annex I, II), and regional requirements across APAC, LATAM, and MEA.
• Proactively monitor regulatory changes and lead updates to PMS & CE processes to maintain compliance.
• Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness.
• Engage effectively with stakeholders across all levels of the global organization, including regional regulatory agencies, to foster strategic relationships, influence policy, and ensure compliance.
• Lead cross-functional collaboration to optimize PMS & CE processes.
• Foster a high-performance culture focused on talent development, succession planning, and continuous improvement.
• Establish and maintain global best practices, standardized policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of PMS & CE work outputs and systems.
• Balance standardization with regional flexibility where necessary.
• Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in PMS & CE activities.
• Lead initiatives for risk mitigation and proactive adaptation of PMS & CE strategies at a global level including PMS /CE requirements or standards, audit findings.
• Ensure PMS & CE team members possess the requisite technical skills, experience, and training to perform their work.
• Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives.
• Foster and maintain a positive, inclusive and productive work environment aligned with Cook’s culture and values.

Requirements

• Third level Qualification preferably in Science/Engineering is required.
• A minimum of 12 years’ experience in a regulated industry in a similar role preferred.
• Comprehensive understanding of PMS & CE related requirements and a broad range of all medical device requirements in accordance with regulatory standards - ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR is required.
• Strong leadership and team management capabilities, with demonstrated success in guiding and developing global teams.
• Ability to lead and deliver multiple complex global projects simultaneously within deadlines.
• Ability to develop and maintain strong working relationships with internal and external stakeholders worldwide.
• Adapt to dynamic landscapes and organizational changes, with the ability to adjust quickly and effectively in a change-driven environment.
• Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision.
• Excellent organizational and planning abilities, complemented by keen attention to detail.
• Demonstrated ability to work in a fast-paced, high-pressure environment and meet deadlines.
• Collaborative team player with a proven ability to foster trust, open communication, and effective collaboration across diverse teams and stakeholders.
• Effective communication and interpersonal skills to build relationships across diverse geographies and cultures.
• Self-motivated and proactive, with a passion for driving quality and operational excellence.
• Flexibility to work across global time zones as required.

Benefits

• Willingness and availability to travel globally on company business.