Regulatory Affairs Specialist
Salary AUD80,000 - AUD90,000 per annum + + super + bonus + health
Location Macquarie ParkFULL_TIME
Consultant Martine Dines
Date posted 17 November 20192019-11-21 2019-12-17 medical-and-nursing Macquarie Park New South Wales Macquarie Park AU 2113 AUD 80000 90000 90000 YEAR Robert Walters https://www.robertwalters.com.au https://www.robertwalters.com.au/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
Regulatory Affairs Specialist will sit within the Quality and Regulations Team and report into the Regulatory Director. You will be hands on with Post Market data and be responsible for Holds, Recall, Complaints etc. Therefore looking for someone with strong stakeholder management skills both internally and externally.
- Follow procedures and all other regulatory requirements
- Execution of Field Corrective Actions including liaison with internal and external stake holders
- Making Regulatory Reportability Decisions and respond to Regulatory Inquiries
- Manage all internal stakeholder relationships and work collaboratively across Complaints, Holds, Recalls
- Return of products associated with complaints
- Analysing data of all inventory reports for product hold and field actions
- Preparation and release of regular reports associated with regulatory actions, and Post Market Surveillance
- TGA Post Market Reviews
- 3+ years of experience working within a certified Quality System.
- Previous experience in either Quality/Regulatory or ideally Post market.
- Knowledge and understanding of applicable external medical device regulatory standards, including TGA, MedSafe, ISO 13485
- Demonstrated organisation and administrative skills (record keeping and data entry)
- Competent analytical and computer skills
- Strong and demonstrable business acumen
- Ability to multi task and manage complexity
- Strong Communication & Interpersonal Skills (verbal and written)
To apply please click apply or call Martine Dines on +61 2 8289 3239 for a confidential discussion.