Global Manager, Post Market Surveillance

Integer Holdings Corporation • Chaska, MN

1d

About The Position

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. 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 Who are we? Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide. We are guided by our six Values, including Customer perspective, Accountability, Agility, One Team, Candor, and Inclusion. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement. What you will do in this role: 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 & develop teams: 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. Manufacturing and Post Market Surveillance Support: 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. Provide support of Integer’s QA/RA Programs: 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 & Problem-Solving: Promote associate engagement through standardized problem-solving, research methodologies, systematic analysis, and transparent reporting, creating a culture of collaboration and accountability.

Requirements

• You have earned, as a minimum, a bachelor’s degree in an engineering or related technical field. A master’s degree is preferred.
• You have at least 5-7 years of experience in environment in which ISO standards’ governance and/or regulatory compliance were expected.
• You have 5+ years of experience in Post Market Surveillance
• Proven leadership experience managing teams and complex projects.
• Strong project management and strategic planning capabilities.
• Excellent communication and stakeholder management skills.
• Technical aptitude with ability to interpret data and drive decisions.
• Resilient, adaptable, and solutions-oriented mindset.

Responsibilities

• Manage the activities of and provide daily direction to the enterprise team of Post Market Surveillance professionals
• Lead efforts to identify potential gaps in existing systems and to drive system and regulatory improvements
• Execute and provide input on activities necessary for Post Market Surveillance within the United States, European Union and International markets
• 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 & Problem-Solving: Promote associate engagement through standardized problem-solving, research methodologies, systematic analysis, and transparent reporting, creating a culture of collaboration and accountability

Benefits

• Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.
• Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.
• We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave is available after one year.
• Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance.
• Employees are immediately eligible to participate in the 401(k) plan with company matching contributions.
• We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees