Director, Post-Market Surveillance and Clinical Evaluation

Cook Group•Bloomington, IN

27d

About The Position

Overview The Director of Post-Market Surveillance and Clinical Evaluation leads the global strategy, governance, and compliance of Post Market Surveillance and Clinical Evaluation activities, ensuring accuracy, regulatory alignment, and continuous improvement across markets through standardized systems and processes. Leads and inspire global teams, fostering a culture of collaboration, accountability, and high performance to ensure consistent delivery of centralized capabilities across all markets. 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, standardised 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. Willingness and availability to travel globally on company business.

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.

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, standardised 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.
Willingness and availability to travel globally on company business.