Regulatory Affairs (Senior) Specialist
Universal Biosensors, Australia

Universal Biosensors (UBI) is a world leading, publicly listed Australian company (ASX:UBI) which develops, manufactures and sells biosensors for use in several industries around the world. Our biosensor technology has been used in more than 10 billion measurements for blood glucose monitoring and blood coagulation in diabetes and coagulation patients worldwide. More recently, we have pivoted our technology into non-medical products, including SENTIA for the global wine industry and Petrackr for the veterinary domain. In addition, we continue to develop new applications for our technology within human health with the imminent US launch for the next generation of coagulation monitoring device, Xprecia Prime, in 2023. Prime is already available for sale in EU!

We are looking for a focused and driven individual to assist our Regulatory amp; Clinical Manager (in our Melbourne office) as a Regulatory Senior Specialist as we prepare for various regulatory submissions related to our Xprecia Prime product approval.

The role will consist of (but not limited to) the following activities:-

• Prepare Medical Device Files for submission to regulatory authorities across the globe
• Maintain Medial Device Files and other regulatory documentation
• Maintain regulatory license databases and systems which contain regulatory approval or restriction information
• Communicate with regulatory agencies and conformity assessment bodies
• Provide regulatory support to existing projects, as necessary
• Perform administrative tasks, including document formatting, and preparing documentation.
• Provide input on PMS, including alignment to FDA, TGA and EU IVDR requirements
• Assist coordinating Post-Market Surveillance activities

Requirements

In addition to Tertiary qualification in Life Science/Health/Pharmacy (or similar), the following skills and qualifications are considered necessary in this role:

• Experience creating regulatory documentation for submission to regulatory authorities is essential
• Experience in either quality assurance or regulatory affairs within a highly regulated industry highly desirable
• Experience preparing regulatory submissions desirable
• Understanding of quality system regulations (ISO13485; 21CFR820) for medical devices as well as risk management and ISO14971 (ISO standard for the application of risk management to medical devices);
• Excellent communication and interpersonal skills
• Highly developed technical writing/ editing skills;
• Ability to acquire, query and analyse data with focus on detail;
• Ability to work flexibly (there may be irregular hours required across different timezones)
• Proven ability to take accountability for the quality, accuracy and timeliness of their work outputs.
• Understand aspects and methods for data analysis, interpretation and presentation desirable.
• Technical writing skills or previous experience
• Understands, interprets, and clearly presents scientific and medical data in verbal and written format (including understanding and application of medical concepts and terminology).
• Excellent Excel skills and MS Suite
• Excellent attention to detail

Benefits

This role is offered on a contract basis for 3-4 months with immediate start and flexibility to extend if the work scope requires. This role can be flexibly performed in a hybrid work arrangement with a fully remote option only available to candidates who can demonstrate their experienced capability to deliver required outcomes. A very competitive remuneration package will be offered to the candidate who can 'hit the ground running'!

If you are that experienced regulatory expert who is happy to roll your sleeves up and get hands on, please apply with your current CV, highlighting your relevant skill sets and experience!

Only apply if you're an Australian citizen/Permanent Resident or holding a valid visa with full working rights in Australia.

Job Rewards and Benefits