Administrative Assistant (Regulatory Affairs)

Unique opportunity to make the move into an innovative global Medical Devices organisation! We are currently seeking a proactive and self-motivated Administration Assistant to support our client in the Macquarie Park area.This role has work-from-home flexibility (1-2 days per week in the office) and will see you supporting a team of professionals by completing administrative tasks surrounding TGA regulations.What's In It For You Temporary assignment for around 8 weeks with the possibility of extension Up to $47 p/h + super (depending on candidate expectations and experience) Monday - Friday, 37.5 hours per week Based from Sydney or Melbourne with hybrid flexibility available Role commencing by end of September 2024 Genuinely interesting position that supports professionals in the post-market division with a variety of administrative tasks Fantastic opportunity to build upon your experience in a well-known, global organisation Opportunity to work autonomously within supportive and relaxed team The Role Follow organisational procedures and all other regulatory requirements when completing your duties Support with the execution of corrective actions surrounding product Recall and Non-Recall, including liaison with internal and external stakeholders Assist with Regulatory reporting and submitting device incident reports where required, in accordance with TGA and similar regulations Respond to Regulatory Inquiries from TGA and other regulatory bodies Managing internal stakeholder relationships, particularly surrounding complaints and recalls Coordinate the return of products where appropriate Analyse data of all inventory reports Prepare and release regular reports associated with regulatory actions and post-market reviews You Will NeedKnowledge and understanding of applicable external medical device regulatory standards including TGS, MedSafe and ISO Demonstrated organisational and administrative skills such as record keeping and data entry Analytical skills and computer competency, with the ability to utilise new systems quickly Ability to multitask and manage a wide variety of tasks and competing deadlines Strong communication and interpersonal skills, both written and verbal Candidates must be able to commit to at least the required duration of the assignment Candidates must be happy attending the office in Macquarie Park when required If this role grabs your interest and you'd like to be considered for the opportunity, please apply with your up-to-date resume today! #J-18808-Ljbffr