Genetic Signatures is a global molecular diagnostics company, driving improved patient outcomes using our innovative 3base™ technology to provide configurable clinically relevant molecular diagnostic solutions for infectious diseases.  We support leading pathology laboratories around the world and with a keen focus on meeting our customer needs, we continue to expand our global customer base.

To help support our growing company, we now seek a proactive and detail oriented Regulatory Affairs Associate to generate documentation required for regulatory submissions.

As the successful candidate you will:

• Generate, maintain and update Regulatory documents to meet domestic and international Commercial and Regulatory requirements
• Liaise with Regulatory Affairs Manager to ensure changes to regulatory strategy are incorporated into regulatory documents
• Liaise with Regulatory Affairs Manager for advice on regulatory activities and preparation of regulatory submissions
• Assist in preparing documents and submissions for company and IVD registration in required jurisdictions including Australia, Europe/UK, USA, Canada and Israel.
• Assist with maintenance of records of regulatory activities and registrations in all jurisdictions
• Liaise with Quality Management Representative to assist with Quality Management System activities, including internal and external audits, as needed
• Liaise and communicate regulatory and quality requirements and timelines with the scientific team as needed
• Identify need for and perform staff training on regulatory or QMS activities as needed

Essential for success as a Regulatory Affairs Associate are:

• A minimum of Bachelor of Science
• ISO 13485, TGA, FDA & HC regulatory requirements
• Sound understanding of molecular biology and IVDs, (e.g., genetics, bioinformatics etc.);
• Attention to detail and record keeping
• Excellent time management and organisational skills with a demonstrated ability to work to deadlines
• Experience in IVD or medical devices or associated software

It is advantageous if your personal talent tool kit includes:

• Bachelor of Science in Biomedical Science or a related field
• Ability to independently source technical information, formulate hypotheses, design experiments and interpret the results
• Knowledge of regulatory requirements in Australia, UK and other jurisdictions
• Experienced in auditing of QMS
• Understanding of relevant scientific, technical and manufacturing background

The successful applicant will be rewarded with a competitive remuneration package, commensurate with experience.

If this sounds like your next career opportunity and you want to make a difference to healthcare outcomes, apply now, we can’t wait to hear from you!

Please apply with a cover letter and CV via Seek. Enquiries can be made via email at [email protected]. All applications will be treated in the strictest confidence. Please note that due to the expected large number of applications, only those who are short-listed will be contacted for an initial interview.

As part of our recruitment process, suitable candidates may be asked to provide a police check and participate in a pre-employment medical.

Genetic Signatures Ltd is committed to providing equal employment opportunities, we thrive on the diversity of thought present in our workforce and encourage anyone possessing the talent and drive to better health care for their community to apply. All qualified applicants will receive consideration for employment without regard to race, colour, religion, national origin, gender, age, sexual orientation, gender identity, disability, status as a Veteran or other protected classification