Manager, Post Market Surveillance

Overview

The Manager, Post-Market Surveillance, is responsible for leading the planning, execution, and oversight of post-market surveillance activities across Cook''s product portfolio. This role provides strategic leadership and technical expertise to a geographically dispersed team, driving robust, compliant Post-Market Surveillance (PMS) programs that meet global and regional regulatory requirements throughout the product lifecycle. The Manager champions standardized systems and processes, and fosters a culture of quality, accountability, continuous improvement, and cross-functional collaboration.

Responsibilities

• Implement, manage, and execute Cook's global post-market surveillance policy and strategy.
• Provide leadership, mentorship and technical expertise to a diverse, geographically dispersed Post Market Surveillance (PMS) team, ensuring alignment with global policies, standards, regional requirements and Cook's business objectives.
• Lead post-market surveillance project planning, ensuring alignment with regulatory timelines and business objectives. Generate and maintain PMS schedules, tracking progress against milestones and managing risks proactively. Monitor PMS metrics to measure program performance and drive data-driven decision-making. Ensure all PMS activities comply with applicable global and regional regulatory requirements.
• Promote and participate in continuous improvement activities within the PMS function, lead initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in PMS activities.
• Engage effectively with regulators and stakeholders across the global organization to foster strategic relationships, influence policy, and ensure compliance. Oversee PMS meeting cadence, facilitating cross-functional alignment on status and priorities.
• Manage PMS resource planning, recruitment, team performance, and development. Drive team training and development initiatives. Foster and maintain a positive, inclusive, and productive work environment aligned with Cooks company culture and values.
• Oversight of the post market performance and safety for medical devices throughout the product lifecycle. Management of PMS actions, ensuring timely resolution and appropriate escalation. Communication of relevant PMS information to Person Responsible for Regulatory Compliance (PRRCs), Senior Management and other functions as required.
• Determine and manage PMS requirements for all Cook devices throughout the product lifecycle including the PMS requirements for divested devices, ensuring appropriate transitional arrangements, provision of the appropriate PMS information for PRAR (Periodic Review/Assessment Report) and oversight of Post-Product Activities (PPA) as relevant/required.
• Review and approve Periodic Safety Update Reports (PSURs) and Post-Market Surveillance Reports (PMSRs), Summary of Safety and Clinical Performance (SSCP), and post market clinical follow up (PMCF) documents.
• Input, collaboration and support to clinical evaluation and PMCF processes and documentation.
• Manage Annual Certificate Surveillance (ACS) submission processes, ensuring completeness and on-time delivery. Review and manage responses to Notified Body deficiencies related to PMS.
• Participation / lead and support of internal and external audits related to PMS activities.
• Drive adherence to relevant Quality Management Systems and business processes, promoting a culture of quality and organizational effectiveness.
• Support the management review process and contribute relevant metrics and updates from post market surveillance.
• Monitor and communicate regulatory intelligence related to post market surveillance & related documentation. Ensure processes and documentation are kept up-to date with the latest requirements, standards and guidance documents in a timely and compliant manner.
• Manage supplier qualification and monitoring activities as they relate to PMS.
• Willingness and availability to travel globally as required by business needs.

Qualifications

Essential Regional or Country RequirementsEducation and/or Work Experience

• Third level Qualification/university degree, preferably in Science/Engineering, is required.
• A minimum of 10 years' experience in a regulated industry in a similar role preferred.

Knowledge and Skills and/or Abilities

• Comprehensive understanding of post market surveillance requirements and a broad range of all medical device requirements in accordance with regulatory standards - ISO13485, EU Medical Device Regulations and other global regulations are required.
• Strong knowledge of EU MDR PMS requirements (PSUR, PMSR, SSCP, PMCF) and other applicable global requirements, standards and guidance documents.
• Proven leadership skills and demonstrated experience leading and managing teams.
• Experience managing regulatory submissions and interfacing with Notified Bodies and/or regulatory agencies.
• Strong project management and organizational skills with the ability to manage multiple priorities.
• Excellent communication and stakeholder engagement skills across a global organization.
• Strategic thinking with the ability to translate regulatory requirements into operational plans.
• Proficiency in Quality Management Systems and regulatory compliance frameworks.
• Demonstrated ability to work in a fast-paced, high-pressure environment and meet deadlines.
• Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision.
• 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.
• Fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers.

Physical Requirements

• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements of the ADA (Americans with Disabilities Act) (US Only)