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Clinical Safety Officer

Dedalus

New Zealand (Hybrid) · Full Time

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Experience
Any
Salary
Openings
1
Posted
4 weeks ago
Work mode
Hybrid
Education
Degree-level qualification in a healthcare-related or managerial discipline, or Registered Pharmacist
Eligibility
Registered clinicians from the healthcare sector with senior or management-level experience who can work in New Zealand and who meet the role’s clinical safety and healthcare IT requirements.
Resume
Required to apply

Job description

Role overview

Dedalus is hiring a Clinical Safety Officer in New Zealand. This is a purpose-driven opportunity to help make healthcare safer, more reliable, and better for patients and clinicians. The position can be carried out remotely or in a hybrid setup from Auckland.

The role calls for a registered clinician from the healthcare sector who has worked at a senior or management level.

What you will do

  • Maintain and review the Hazard Register and produce the key clinical safety documentation.
  • Advise on ways to reduce and manage the clinical risks identified.
  • Build safety and regulatory requirements into the Software Development Lifecycle as a standard part of delivery.
  • Support compliance with global safety laws and regulations, including EU Medical Device Regulation (EU) 745/2017.
  • Assist with registration and certification of Dedalus medical device and software products for global market access.
  • Help establish a structured, cost-effective safety approach across the company based on legislation, standards, and best practice.
  • Identify safety issues earlier in product development to lower the likelihood of incidents, reduce delays, and control costs.
  • Contribute to reducing litigation exposure by ensuring rigorous development and documentary evidence related to patient safety.
  • Use clinical expertise to shape business processes so that clinical requirements and regulatory obligations are properly addressed.
  • Review test results to confirm the solution has been assessed for clinical safety and effectiveness, and that mitigation actions are in place.
  • Escalate project and programme risks or issues through the correct internal channels when needed.

Essential requirements

  • Working knowledge of healthcare IT, or experience using systems such as hospital information systems or picture archiving and communication systems.
  • Registered Pharmacist status, or a degree-level qualification in a healthcare-related or managerial discipline, or equivalent experience.
  • Ability to provide clinical consultancy, approve the clinical safety case, assess clinical risks, and compile safety cases.
  • Experience carrying out health hazard evaluations for post-market incidents.
  • Capability to perform the clinical safety activities needed to satisfy internal and external requirements for a product or release.
  • Strong understanding of regulations and standards, with the ability to explain them to non-specialist audiences.
  • Comfort working across multiple products and tasks at once, shifting priorities efficiently without losing track of other responsibilities.
  • Broad knowledge of healthcare IT processes and workflows within clinical settings, plus the ability to explain product purpose, function, and structure to non-clinical colleagues.
  • Ability to guide non-clinical stakeholders in understanding clinical hazards and impact assessments.
  • Experience communicating with regulatory agencies and notified bodies regarding registration, certification, incidents, and reportable corrections.

Preferred experience

  • Background in risk management for medical devices or clinical products, such as ISO 14971 or DCB-0129.
  • Experience working in a regulated environment.
  • Familiarity with relevant standards and regulations, including (EU) MDR, (EU) IVDR, ISO 13485, IEC 62366, IEC 62304, ISO 9001, and ISO 27001.
  • Ability to work independently from home with limited in-person contact.
  • Confidence adapting to change and managing shifting priorities.
  • Ability to complete assigned work within agreed timeframes.

About Dedalus

Dedalus develops healthcare software that supports clinicians and nurses in delivering better care. The organisation emphasizes learning, innovation, and clinical cooperation, with the aim of improving healthcare services and outcomes for patients around the world. The company operates across more than 40 countries and has a workforce of 7,600 people.

Additional information

Application closing date: 14 July 2026.

Diversity and inclusion

Dedalus states that it is committed to an inclusive and diverse workplace and aims to create an environment where all colleagues and communities are treated with respect and supported to succeed.

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