Our Client
Our client is an Australian Biotechnology success story transforming molecular diagnostics. Their proprietary molecular diagnostics platform technology provides hospitals and pathology laboratories the ability to screen for a wide array of diseases and infectious pathogens with a high degree of specificity and with rapid high throughput. Their continued long-term goal is to target health conditions where faster and more accurate diagnosis plays a pivotal role in improving community health both in Australia and across the globe. Now is an exciting time to be joining our client as they undergo further expansion.
 
The Opportunity
We are seeking an experienced Regulatory Affairs Associate. You will assist our client’s team to generate and maintain documentation for domestic and international regulatory submissions for their regulated in vitro diagnostic device products (IVDs). Reporting to the to the Regulatory Affairs Manager, your key activities include assisting in:

• Writing and reviewing product documentation including design records, technical files, device instructions and labelling.
• Generation of testing and validation documentation including protocols and reports.
• Design, documentation and result analysis of clinical trials.
• Spreadsheet and software validation.
• Maintenance of QMS documentation via our eQMS software
• Regulatory submissions and correspondence with regulatory bodies.

Position Requirements

• At least 3 years previous Regulatory Affairs experience in a medical device, pharmaceutical or healthcare setting.
• Clinical trial experience.
• Experience in a TGA, FDA, IVDD/R registered environment
• Strong understanding of ISO 13485 Quality Management principles
• Excellent verbal and written communication skills
• Proven experience writing and reviewing medical device documentation
• A BSc. in Biomedical Science or a related field
• An understanding of Molecular biology including Real-time PCR
• Excellent time management and organisational skills

Our Offer
Our client offers an exceptionally dynamic and progressive work environment. This role is at the frontline of development of new innovative technologies. They expect, and provide, excellent professional standards and work ethics. As a valued member of this team, you will have the opportunity to demonstrate your talent and shape this new and exciting company.
 
If you are interested in joining our client in this exciting new challenge, please call Marilyn Jones on 0437 332 272 for a confidential discussion and/or email your résumé with your cover letter to careers@mexeccareers.com