Global Manager, Post Market Surveillance jobs in United States
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Integer Holdings Corporation · 2 weeks ago

Global Manager, Post Market Surveillance

Integer Holdings Corporation is a global organization providing innovative technologies and manufacturing to enhance the lives of patients worldwide. The Global Manager of Post Market Surveillance will manage a team of professionals to ensure compliance with regulatory requirements and drive continuous improvement initiatives in Post Market Surveillance processes.

Health CareManufacturingMedicalMedical Device

Responsibilities

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
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

Qualification

Post Market SurveillanceISO standards complianceProject managementData analyticsRegulatory knowledgeStakeholder managementStrategic planningLeadershipCommunication skillsProblem-solving

Required

You have earned, as a minimum, a bachelor's degree in an engineering or related technical field
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

Preferred

A master's degree is preferred

Benefits

Medical
Dental
Vision
Disability
Life insurance
Adoption benefits
Parental leave
Supplemental life insurance
Critical illness
Hospital indemnity
Accident insurance
401(k) plan with company matching contributions
80 hours (10 days) of company designated holidays per year
Annual allotment of paid time off

Company

Integer Holdings Corporation

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Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.