As a specialist recruitment partner, we are proud to be supporting a high-growth New Zealand medtech organisation in the search for a Quality and Regulatory Manager.

This is a pivotal leadership role, sitting on the senior leadership team and reporting directly to the CEO. You will take ownership of the Quality Management System (QMS) and regulatory strategy, ensuring products meet the highest global standards while enabling ongoing market access.

This role will suit an experienced quality and regulatory professional who thrives in a dynamic environment, enjoys influencing at an executive level, and is passionate about building a strong, proactive quality culture.

What you will do

• Lead and maintain QMS in line with ISO13485, GMP and regulatory requirements
• Drive continuous improvement through gap analysis and raising quality standards
• Oversee audits (internal and external) and ensure successful certification outcomes
• Manage regulatory approvals and ensure ongoing compliance across key markets
• Lead, mentor and develop the Quality and Regulatory team
• Partner with senior leadership to influence and embed a strong quality culture
• Oversee risk management programmes and ensure product compliance
• Manage customer complaints, CAPAs, and quality reporting

What we are looking for

• Proven experience with ISO13485 and Medsafe regulatory requirements
• Strong background across quality and regulatory in medtech, pharma, or related sectors
• Demonstrated leadership experience, with the ability to influence at exec level
• Experience conducting gap analysis and implementing system improvements
• Excellent communication skills and ability to engage diverse stakeholders
• A proactive, solutions-focused mindset with strong attention to detail

What’s in it for you

• Senior leadership role with direct influence on business strategy
• 4 day working week 
• Health Insurance
• Generous salary package aligned with experience
• Share options included
• Opportunity to shape and elevate quality culture across the organisation
• Work within an innovative, purpose-driven medtech environment
• Autonomy, ownership, and the ability to make a tangible impact

How to apply Click APPLY NOW or call Belinda at Scitex Recruitment on 09 200 3121 for a confidential discussion.

To apply for this vacancy, you MUST be a New Zealand citizen, or resident, or have already secured the right to work in New Zealand and therefore hold a valid visa.

Scitex specialises in permanent, contract and temporary recruitment – and has done so since 1987. We are here to engineer better Mondays.
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