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Job type: Permanent

Discipline: Operations

Location: New Zealand

Ready to lead product quality beyond approval and make a real impact on patient safety?

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� 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.

If you are having difficulty in applying or if you have any questions, please contact Pamela Phoumavong at p.phoumavong@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is acting as an Employment Agency in relation to this vacancy.

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