Address Randstad is currently assisting a Federal Government Agency in engaging with a highly skilled APS6 Medical Device Assessor/ regulatory and technical Officer. This is a great opportunity for an experienced professional to bag a contract with a highly-sought after Department.
The opportunity is available for 6 Months initial contract with the possibility of extension.
Key responsibilities:
You will be working with high-performing teams who are responsible for:
Undertaking under limited direction, regulatory and technical assessment of the applications for Medical Devices, including evaluation of the technical documentation and data, collating expert advice relevant to the assessment, and preparing a clear statement of reasons based on the investigation findings and knowledge of the regulations
Providing timely, quality and accurate advice issues relating to Medical Device regulation.
Communicating with relevant stakeholders, including providing advice and feedback on the outcomes of application assessment.
Dealing with complex issues and managing stakeholders under limited direction.
Managing record keeping in accordance with the regulatory requirements and whole of- government policy and standards.
Providing inputs and advice to the policy development and business improvement related to Medical Devices when required and where appropriate.
Capabilities:
A high degree of experience, knowledge or familiarity with Medical Devices and regulatory requirements
Demonstrated ability to interpret and apply legislative and regulatory frameworks, guidelines, and policies and analyse technical information to make informed decisions.
Demonstrated ability to prepare high quality regulatory decision letters, notices and communications.
Demonstrated ability to adapt to changes in regulations, guidelines and policies relating to Medical Devices, and be able to quickly learn and implement new regulatory requirements.
High level of attention to detail, accuracy, and consistency in performing regulatory tasks.
Strong communication skills, including the ability to communicate effectively with multiple stakeholders.
Ability to meet multiple deadlines with conflicting priorities.
Ability to work collaboratively in teams.
Sound judgment, attention to detail and organisational skills and ability to take responsibility for work, prioritising tasks and producing quality outputs to meet tight deadlines
Mandatory Qualifications:
Relevant higher education qualification in health or science related field of studies or biomedical engineering
Eligibility and other requirements
All applicants are required to be an Australian citizen and have the ability to obtain and/or maintain Baseline security clearance.
If you would like to be considered for this role, this is a great opportunity to tell Randstad about you. Please click “Apply Now” to submit your current resume in word format (.doc or .docx), or send it to destiny.eze@randstad.com.au or call on 0261323809 for any additional enquiries.
Please note only successful candidates will be contacted.
