Global Manager, Post Market Surveillance

Global Manager, Post Market Surveillance – Integer Holdings Corporation

• Customer:
  We focus on our customers’ success
• Innovation:
  We create better solutions
• Collaboration:
  
  We create success together
• Inclusion:
  We always interact with others respectfully
• Candor:
  We are open and honest with one another
• Integrity:
  We do the right things and do things right

The primary purpose of this role is to manage the activities of and provide daily direction to the enterprise team of Post Market Surveillance professionals, to ensure that requirements, performance goals and improvement objectives for integer owned products are achieved. In addition, you may lead efforts to identify potential gaps in existing systems and to drive system and regulatory improvements required to enable your department to execute at an efficient level.

Your primary purpose is to execute and provide input on activities necessary for Post Market Surveillance within the United States, European Union and International markets, and ensure compliance with relevant FDA, EU, ISO, and other Post Market Surveillance regulatory requirements and standards.

• Build, mentor, and inspire a high‑performing team of Post Market Surveillance professionals.
• Establish a culture of quality and compliance aligned with Integer’s Quality Management System.
• Set clear objectives, provide continuous feedback, and support Individual Development Plans to grow technical and leadership capabilities.
• Promote collaboration, accountability, and cross‑functional alignment across global sites and business units.
• Champion diversity, inclusion, and safety, ensuring open communication and trust within the team.

• Develop and execute a global PMS strategy that aligns with regulatory requirements and business objectives.
• Serve as the leader for the PMS Group, influencing organizational decisions and shaping best practices.
• Monitor emerging regulatory trends and proactively adapt processes to maintain compliance and competitive advantage.
• Drive continuous improvement initiatives leveraging data analytics, risk management, and predictive insights.
• Develop global PMS dashboards and reporting systems for local management and executive visibility.
• Lead training programs to elevate PMS knowledge across the organization.
• Oversee complaint handling, ensuring timely and thorough investigations, root cause analysis, and corrective actions.
• Manage high‑priority projects and escalations, coordinating cross‑functional resources to resolve complex issues.
• Lead interactions with regulatory agencies, audits, and inspections, ensuring readiness and successful outcomes.
• Own, resource planning, and strategic goal setting.
• Partner with Quality Assurance, Regulatory Affairs, R&D, and Manufacturing to integrate PMS insights into product lifecycle management.
• Support product recalls, field actions, and risk mitigation strategies with precision and transparency.
• Drive engagement in standardized problem‑solving methodologies and data‑driven decision‑making.
• Implement advanced tools and analytics to identify trends, predict risks, and improve product performance.
• Foster a culture of continuous improvement, encouraging innovative approaches to PMS processes.
• Other duties as assigned by your manager.

• Champion Quality:
  You set the standard for quality across Integer, living the principle of "I own Quality" and driving the achievement of key performance indicators on our journey toward differentiated quality.
• Advance Strategic Initiatives:
  Actively support Integer’s Manufacturing Excellence and Market‑Focused Innovation strategies, ensuring Post Market Surveillance aligns with broader business goals.
• Deliver PMS Strategy:
  Lead the execution of Integer’s Post Market Surveillance roadmap, translating strategy into measurable outcomes that enhance compliance and customer trust.
• Drive Continuous Improvement:
  Oversee quality improvement initiatives focused on PMS, leveraging data‑driven insights and best practices to elevate performance and mitigate risk.
• Foster Engagement &…