Regulatory Affairs and Quality Co-Ordinator
Anatomics is a St Kilda based and Australian owned medical device company that has been manufacturing and marketing innovative surgical products to surgeons locally and internationally since 1996. Anatomics is looking for a high calibre individual to join their dynamic and creative St Kilda office to help support the Vice President Quality and broader leadership team. Reporting to the VP Quality, this is a critical position requiring an organised and self-motivated person with a medical device regulatory background that is capable of thriving with a diverse work profile.
This is a great opportunity to work 3 days a week as part of an expanding organisation assisting in planning and implementation of regulatory activities to achieve and maintain regulatory compliance throughout Australia and Worldwide. The Melbourne based role will involve:
- Work with the VP Quality to prepare and maintain product Technical Dossiers, Design History Files and Device Master Records;
- Prepare and file regulatory submissions and manage regulatory review processes
- Prepare and submit timely applications to the Prosthetic List Advisory Committee (PLAC) for reimbursement of medical devices in the Private Hospital setting.
- Monitor current product registrations and to ensure continuing compliance with post market regulatory requirements
Successful applicants will have the following skills and experience :
- Tertiary qualification in science or related field
- Excellent communication, both written and verbal
- 1-2 years Regulatory experience, within the medical device industry desirable
- Previous experience compiling and maintaining complex Design Dossiers
- Experience with major submissions to the TGA (FDA and EU experience desirable)
Initial and ongoing training is provided to equip you with the technical, medical, business and sales skills necessary to succeed.
If you believe you meet the above criteria click apply now to submit your resume to [email protected] or call (03) 9529-8088 for more information.