Senior Regulatory Affairs Specialist

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 2024. Prime is already available for sale in EU!
We are looking for a focused and driven individual to be our Senior Regulatory Affairs Specialist (in Melbourne HQ) with expertise in developing and implementing a clear global regulatory strategy for all UBI product development and commercialisation plans.
The role will consist of (but not limited to) the following activities:-

• Lead product regulatory approval projects for key markets, including EU and US.
• Responsible for clinical & vigilance aspects of new and 'in-market' products
• Prepare and maintain Medical Device Files for submission to regulatory authorities across the globe
• 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
• 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/Medical/Engineering (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 is essential
• 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
The successful candidate will enjoy the following benefits:-

• Training & Development
• Employee Assistance Program (wellness and counselling benefits)
• Vibrant & Collaborative Work Culture
• Novated Leasing via Salary Packaging

This is a rare opportunity with a strong and successful business for someone who has the ability to anticipate needs, adapt and stay focused in a fast-paced environment! If you feel you’re ready to take the step forward, let's do it! Please apply with your current CV, highlighting your relevant skill sets and experience! 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.