Post Market Surveillance Manager

Proclinical; Auckland; Presencial; NZD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Proclinical is seeking a Post Market Surveillance Manager to lead post-market activities for medical devices and strengthen patient safety across global markets. The role focuses on QMS compliance, regulatory requirements, and driving quality improvements.

You will develop strategic plans, build a high-performing team, and collaborate with cross-functional partners to minimize regulatory risks while aligning quality initiatives with business objectives.

Formación

• 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.

Responsabilidades

• Lead all aspects of post-market surveillance and address potential risks in the field.
• Ensure compliance with QMS and regulatory requirements, including timely reporting to authorities.
• Analyze post-market data and communicate insights to minimize regulatory risks.
• Develop and implement global quality and regulatory strategic plans.
• Develop strategies to provide competitive advantage in post-market surveillance.
• Continuously improve post-market surveillance practices and tools.
• Build and lead a high-performing quality/regulatory team.
• Monitor external regulatory environments for changes and act accordingly.
• Collaborate with cross-functional teams to align quality initiatives with business goals

Conocimientos

Leadership

QA/Regulatory

Stakeholder comms

Regulatory authorities

Team leadership

Strategic planning

Problem-solving

Educación

Bachelor's degree or equivalent in engineering, science, business

Descripción del empleo

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.