Experience

Therapeutic Goods Administration

• Government Administration
• 400 - 500 Employee

• Acting Director

  • Aug 2022 - Present

• Senior Medical Devices Auditor and MDSAP Assessor

  • Jun 2015 - Aug 2022



Resonance Health

• Perth Area, Australia

• QA and Regulatory Affairs Manager

  • Oct 2008 - Jun 2015

  Responsibilities and Competencies • Maintain the currency and effectiveness of quality system documentation (ISO 13485 based) through a process of continual improvement. • Thorough knowledge of FDA, EU, TGA and Health Canada cGMP’s and corresponding Regulatory requirements. • Ensure ongoing internal audits of the quality management system are conducted. • Manage site calibration and validation programs. • Compiling and analysing department and company KPI’s and driving continuous improvement. • Manage the Supplier Evaluation System. • Review and sign-off on quality documentation including the release of product. • Manage the CAPA, Planned Deviation, Change Control, Continuous Improvement, Complaints, Pest Control and Non Conformance systems. • Project management of design control projects for new products and product updates, including write and review specifications, validation protocols and validation reports. • Act as Management Representative for the company. • Chair Management Review Meetings. • QA Representative in sponsored clinical trials to support regulatory submissions. Manage GCP compliance for contracted clinical services (Novartis drug trials). • Induction training of new staff in the quality management system and the ongoing training of existing staff. • Responsible for all day to day management and activities of the Quality and Regulatory Affairs department, including the development of the departmental budget. • Responsible for all Regulatory Affairs related activities associated with the commercial rollout of devices, including regulatory approvals, issues arising and maintenance of compliance and translation requirements in a variety of international jurisdictions. • Compiled two successful 510(k) submissions, one Aus/EU Regulatory submission and one FDA De Novo Companion Diagnostic submission. • Act as the company Privacy Officer. • Document and Record control. www.resonancehealth.com Show less



APHS Packaging

• Hospitals and Health Care
• 1 - 100 Employee

• Facility Manager

  • May 2008 - Oct 2008



PharmAust

• Quality Assurance Manager

  • Jun 2006 - May 2008



Chemeq Limited

• Validation Specialist

  • 2003 - 2006



Pfizer PGM (Perth)

• Senior Validation Officer

  • 1998 - 2003