Quality & Regulatory Officer

Based in the vibrant and regenerating city of Christchurch, Canterbury Scientific is a prominent figure in the global medical diagnostic sector. We take pride in being a leading OEM supplier, specializing in high-quality, stable IVD Controls for diabetes and hemoglobinopathy assays.

At Canterbury Scientific, our core ethos revolves around customer-centricity. We meticulously focus on every aspect of our products, from design and development to manufacturing. Our goal is to tailor our offerings precisely to our customers' specifications and regulatory requirements under ISO 13485, EU IVDR and US FDA 21 CFR 820, ensuring that the result not only meets but consistently exceeds their expectations and requirements.

With an unwavering passion for excellence, our team of professionals is united by a shared mission: to revolutionize the medical diagnostic landscape and contribute to the well-being of individuals on a global scale. Rooted in a legacy of cutting-edge innovation and adherence to the highest industry and regulatory standards, Canterbury Scientific remains a driving force in shaping the future of healthcare.

As the Quality and Regulatory Officer at Canterbury Scientific, you will hold a pivotal role in assuring the quality, safety, and adherence to regulations of our products and processes. Your diverse responsibilities will encompass:

• Quality Management: Champion the implementation, review, and communication of the Quality Management System (QMS) across the company, ensuring alignment with ISO standards and regulatory standards.
• Regulatory Excellence: Uphold strict compliance with US FDA regulations, CFR 820 regulations, ISO standards (including ISO 13485 and ISO 14971),EU CE IVDR  and other industry requirements. Assist, review, and coordinate regulatory submissions for product approvals and restrictions globally.
• Customer Relations: Manage customer feedback, complaints, and inquiries, nurturing exceptional client relationships and ensuring utmost satisfaction.
• Risk Management: Assist with comprehensive risk management strategies, guaranteeing thorough assessment and effective mitigation tactics.
• Document Management: Supervise document control workflows, including the review and endorsement of Batch Manufacturing Records, issuance of Certificates of Analysis (CoA's), and final product documentation approval.
• Audit Prowess: Lead both internal and external audits, spanning regulatory, certification, and customer assessments. Active participation in QMS meetings and Management Reviews.
• Innovation Advocate: Drive projects devoted to elevating quality standards, fostering a culture of continuous improvement, and mentoring colleagues in quality system best practices.

Qualifications:

• Tertiary qualification in Science and/or Quality Management, ideally a Masters degree.
• Minimum of 5 years' experience in the Biotech, Medical Device, or Pharmaceutical sector, with a strong preference for roles of similar nature.
• Robust foundation in Quality Management, encompassing ISO standards (ISO 13485, ISO 14971), and proficiency in US FDA and EU regulations.
• Proven prowess in internal and external audits, risk management, and change control.
• Analytical acumen and structured approach to complex problem-solving.
• Enthusiasm for instilling a pervasive company-wide quality culture and driving process enhancement.

Benefits:

• Competitive remuneration.
• Opportunity to significantly influence global healthcare and drive tangible change.
• Collaborative and innovative work environment that nurtures professional growth.
• Elevate your career by joining Canterbury Scientific's accomplished team, where your dedication to quality and regulatory excellence can shape the future of healthcare.

Applicants must be a New Zealand Citizen or Permanent Resident to be considered.

To apply, please submit your resume and a cover letter detailing your relevant qualifications and experience. For a confidential discussion about the role, please contact Steve Kennedy on 021 223 2850 or Jenny Barr on 021 223 5118.