Post Market Surveillance Manager / Post Market Surveillance Manageress

Post Market Surveillance Manager

Ready to lead product quality beyond approval and make a real impact on patient safety? Proclinical is seeking a Post Market Surveillance Manager to lead and manage post-market surveillance activities for medical devices. 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.

Apply online using the form below. Please note that only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.