Global Post-Market Surveillance & Quality Leader

Proclinical; Auckland; On-site; NZD 120,000 - 160,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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

Skills

Leadership

QA/Regulatory

Stakeholder comms

Regulatory authorities

Team leadership

Strategic planning

Problem-solving

Education

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

Job description

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.