Job Opportunity
Virax Biolabs, a pioneering biotechnology company, is seeking an experienced Compliance Assurance Director to lead its efforts in obtaining dual ISO 13485 and ISO 9001 certifications. This role will involve creating and managing necessary documentation and processes, leading the submission process, and coordinating all activities required to achieve these certifications.
In this position, you will be responsible for ensuring that all documentation and processes remain up-to-date and compliant after certifications are obtained. You will work closely with product development and manufacturing teams to ensure alignment with quality standards.
About the Role
* Lead the development and implementation of the Quality Management System (QMS) for ISO 13485 and ISO 9001 certifications.
* Create and manage technical files, Standard Operating Procedures (SOPs), risk management reports, and other required documentation.
* Serve as the main point of contact for external auditors and certification bodies.
* Perform internal audits and drive continuous process improvements.
* Train and educate internal teams on quality management processes.
This is a fantastic opportunity for someone looking to have full ownership of compliance assurance and processes within a small, fast-growing biotechnology business, making a significant impact on healthcare for chronic patients.
We offer a competitive salary package of $120,000 - $150,000 per year, performance-based bonus plans, employee stock options program, and 28 days of annual leave + Bank holidays.