APS5 Regulatory Officer

Join a specialist Federal Government team undertaking evidence-based regulatory and technical assessments.

Your new company 
This Federal Government agency is seeking an experienced APS5 Regulatory Officer to join a specialist team responsible for assessing applications and supporting regulatory decision-making. This is an opportunity to contribute to important work within a complex, evidence-based regulatory environment. The role would be on a labour hire basis for an initial 6 months with the possibility of a 6 month extension. 
Your new role 
Working under general direction, you will undertake regulatory and technical assessments involving complex documentation and data. You will apply relevant legislation, regulatory frameworks, policies and established procedures to prepare clear, accurate and defensible assessment outcomes.
Your responsibilities will include:

• Assessing applications and evaluating supporting technical documentation and data
• Reviewing proposed changes, supply-related applications and verification activities
• Collating relevant information and expert advice to support regulatory decisions
• Preparing evidence-based assessment outcomes, decision letters, notices and statements of reasons
• Interpreting and applying legislation, regulatory frameworks, policies and guidelines
• Providing timely and accurate advice on regulatory matters
• Engaging with internal and external stakeholders regarding assessment requirements and outcomes
• Maintaining accurate records in accordance with regulatory and whole-of-government requirements
• Contributing to policy, process and business improvement initiatives
• Escalating complex or sensitive matters appropriately

What you'll need to succeed 
To be successful in this position, you will demonstrate:

• Experience assessing complex technical, scientific or regulatory information
• The ability to interpret and apply legislation, regulatory frameworks, policies and guidelines
• Strong analytical skills and sound evidence-based judgement
• Excellent written communication skills, including the ability to prepare clear and defensible regulatory documentation
• High levels of accuracy, consistency and attention to detail
• Strong stakeholder engagement and interpersonal skills
• The ability to manage conflicting priorities and meet tight deadlines
• A flexible and adaptable approach in an environment where priorities may change
• The ability to work independently under general direction while contributing effectively within a collaborative team

Experience undertaking regulatory or technical assessments within the medical device, health, science or broader regulated-product environment will be highly regarded. Knowledge of Australian medical device regulation and relevant legislative instruments would also be advantageous.
A qualification in health, science, biomedical engineering or a related discipline is highly preferred. 
What you'll get in return 
You will have the opportunity to contribute to nationally significant regulatory work within a collaborative Federal Government environment. This is a full-time labour hire contract based in Canberra, offering exposure to complex technical assessments, regulatory decision-making and continuous improvement activities.
What you need to do now 
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or email kylie.garcia@hays.com.au
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
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