Address
Form of workAllygroup is seeking a highly motivated Medical Device Assessor at the APS6 equivalent level for an initial 6-month contract, with the possibility of a 12-month extension, with our high-profile Federal Government client.
The ideal candidates will have experience, knowledge or familiarity with Medical Devices and disinfectants and their regulatory requirements in Australia, the European Union and other regions.
Candidates must have a relevant higher education qualification in health or science related fields of study, or biochemical engineering.
Duties include:
- Undertaking under limited direction, regulatory and technical assessment of the applications for Medical Devices and disinfectants, 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 and disinfectant 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 and disinfectants when required and where appropriate.
- Contributing to a positive, collaborative and diverse workplace culture in line with the APS Code of Conduct and iCare Values.
Our ideal candidate
Prior experience in this and related fields is mandatory, including:
- 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.
- Ability to adapt to changes in regulations, guidelines and policies related to Medical Devices and disinfectants, 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 multi-task in a fast-paced environment.
- 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
- Maintains a flexible attitude, understanding that priorities may change without notice and able to focus on new priorities in accordance with the strategic direction
- Proven ability to produce work requiring little or no revision before finalisation.
What you need to do now
To apply, click the ‘Apply for this job’ button above or send a current resume and cover letter to our team at ***********@allygroup.com.au expressing your interest in this opportunity. For a confidential talk in relation to this position, please call us on 02 5104 3***.
What's in it for you?
- Attractive renumeration
- Opportunity to join dynamic branch within a Federal Government Department
- Attractive employee referral programs
- Opportunity to join an industry leading legal services recruitment agency which provides ongoing opportunities for professional development and high profile connections within the Federal Government
About Allygroup
Allygroup is a law firm which specialises in legal management consultancy, legal project management and legal recruitment.
Allygroup is an equal-opportunity employer. We encourage applicants from diverse backgrounds and endeavour to put forward the best candidates regardless of any disability or cultural, gender or religious identity.
