Post Market Surveillance Manager

Lead Product Quality and Patient Safety

Ready to lead product quality beyond approval and make a real impact on patient safety? This role focuses on ensuring compliance with quality management systems (QMS) and regulatory requirements while driving quality improvements. You will play a key role in minimizing regulatory risks, developing strategic plans, and leading a high-performing team.

Responsibilities

• Lead all aspects of post-market surveillance, including identifying, assessing, and addressing potential risks in the field.
• Ensure compliance with QMS and international regulatory requirements, including timely reporting to regulatory authorities.
• Analyze and communicate post-market surveillance data internally and externally to minimize regulatory risks.
• Contribute to the development and implementation of global quality and regulatory strategic plans.
• Develop and deploy strategies that provide a competitive advantage in post-market surveillance.
• Continuously improve post-market surveillance practices and tools to achieve world-class standards.
• Build and lead a high-performing team of quality and regulatory professionals.
• Monitor external regulatory and industry environments to identify and implement necessary changes.
• Collaborate with cross-functional teams to align quality initiatives with business objectives.

Key Skills and Requirements

• Proven leadership experience in the medical device or pharmaceutical industries.
• Strong background in quality assurance and/or regulatory affairs, with expertise in US FDA requirements.
• Ability to effectively communicate with senior management and stakeholders across a global organization.
• Experience interacting with regulatory authorities, including during inspections and audits.
• Demonstrated ability to develop and lead high-performing teams.
• Bachelor's degree or equivalent in engineering, science, business, or a related field.
• Strategic planning and financial management skills.
• Strong problem-solving, conflict resolution, and influencing abilities.