Benefits 

• Hybrid WFH - Work from home and in the office - locations Sydney, Melbourne, Brisbane or ACT 
• Ideal target is 37.5 hours Monday - Friday 9am-5pm or min 3 days a week work load 
• Suitable for an AHPRA Registered Doctor with an interest in Public Health and Epidemiology  
• Rewarding, fulfilling and interesting role, utilising your clinical and non clinical skills  
• August 2023 start- one year contract  

The Organisation  
This business unit, is the department that is responsible for the regulation of therapeutic goods, including prescription medicines, vaccines, medical devices, blood and blood products, and tissues and cellular therapies, in Australia. The organisation is part of the Australian Government Department of Health and is responsible for ensuring that therapeutic goods available in Australia are of an acceptable standard of quality, safety and efficacy. The company also works to ensure that Australians have timely access to therapeutic advances. There are plenty of career advancement opportunities for doctors.  


The Position 
A position will be available around August, 2023 for a qualified and experienced  AHPRA Registered Medical Officer with a special interest in Public Health or epidemiology or in clinical research. In this role, you will be responsible for working with a team of around 40 staff to work across 70 different medical specialities, to evaluate and monitor latest medical devices medical devices  products from Cat 1 to Cat 4 to see if they meet specific standards and ensure that Australians have timely access to therapeutic advances. 


Key Responsibilities:

• Undertake evaluation (critical assessment) of complex submissions of clinical data and provide recommendations to the Delegate on whether the Essential Principles are met for medical devices subject to pre- or post- market review.
• Prepare concise written reports detailing the outcome of the evaluation and analysis and detail recommendations in a logical and scientific manner.
• Evaluate instructions for use for medical devices to determine whether all relevant information is adequately communicated and recommend changes where appropriate.
• Assess applications for the supply of unapproved medical devices and make administrative decisions in that regard.
• Contribute to the provision of high-quality medical/clinical advice on regulatory issues 
• Contribute to the development and revision of regulations, technical and administrative procedures, guidelines, SOPs, policies, new work processes, and the adoption of guidelines and standards 
• Assist with the training and mentoring of Medical Officers Class 2 and scientific/ technical assessors across the range of tasks performed at their respective levels.

Key Capabilities:

• Understanding of Australian Health care system by having hands on experience in the clinical setting
• Ability to operate within the boundaries of organisational processes and legal and public policy constraints.
• Excellent consulting, sharing, and communication skills to convey complex clinical matters to diverse stakeholders.
• Judgement with the ability to take responsibility for decisions and manage escalated matters.
• Well-developed written and verbal communication skills with great attention to detail.
• Ability to work under pressure, balance a diverse workload, and complete tasks within given time frames.

Desirable Experience:

• Post-graduate tertiary qualifications in relevant fields, e.g. Public Health, Epidemiology, Clinical Trials.
• Fellowship of an Australian medical college, or working towards.
• Some understanding of GCP standards, desirable but not essential 
• Familiarity with critical review of peer-reviewed medical publications, data 
• Genuine interest in further pursuing a non clinical medical officer career in public health. 

Requirements 

• AHPRA Registered 
• Australian Citizen 
• Excellent communication skills 
• Clinical experience in the Australian Health care System  

How to Apply 

Please contact Sandra Louey on 0403039232 or email slouey@hpgconnect.com  

About the Recruiter  
Sandra Louey offers more than 17.5 years of experience working as an APAC HR Business Partner, In house and External Agency Recruiter.  Sandra is passionate about helping organisations identify top talent, produce high performing teams and work with candidates to help them realise their full potential.  Sandra enjoys helping candidates go on to have fulfilling careers where they feel empowered,  valued, appreciated and respected.