Executive Level 1

**Job Reference Number **23-MDPQDIV-16576

**Classification **Executive Level 1

**Job Title **Medical Device Auditor

**Division **Medical Devices and Product Quality Division

**Branch **Medical Devices Surveillance Branch

**Section **Devices Quality Audit and Assess Section

**Location **Fairbairn ACT, Brisbane QLD, Parramatta NSW, Melbourne VIC

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$108,680 - $123,951

**Mandatory Qualifications **Tertiary qualifications in medicine, science or engineering (for
example in microbiology, chemistry, computer hardware or
software, material sciences or biomedical engineering) from an
Australian institution or comparable overseas qualification.

**Contact Officer Name**:Andrew Bathgate
**Phone**:(02) 6289 3587

**Eligibility**
- To be eligible for employment with the Department of Health and Aged Care,

applicants must be an Australian citizen at the time an offer of employment is made.
- An applicant’s suitability for employment with Health will also be assessed through a

variety of pre-employment check processes, such as:

- Satisfactory completion of an Australian Federal Police criminal history check,
and where relevant a Working with Children and Vulnerable People Check.
- Completion of a medical declaration and pre-employment medical (where
required).
- Providing evidence of qualifications.
- Obtaining and maintaining a security clearance at the required level.

**Division Responsibilities**

The Medical Devices and Product Quality Division (MDPQD) is responsible for undertaking
for supply in Australia. It is also responsible for the ongoing monitoring of medical devices to
ensure they meet the necessary standards throughout their lifecycle. The Division works to
ensure Australian and international therapeutic goods manufacturers meet specified
standards and provide laboratory services.

**Branch Responsibilities**

The Medical Devices Surveillance Branch contributes to the vision of the Health Products
Regulation Group (HPRG] and wider Department 'Better health and wellbeing for all
Australians through monitoring medical devices, including in vitro diagnostic tests (IVDs) and
other therapeutic goods [OTGs), throughout their lifecycle to ensure they continue to meet
an appropriate level of quality, safety and performance. The Branch undertakes complex
monitoring, analysis investigation and review activities for post market regulatory
monitoring and reforms, and keeps abreast of emerging technology and adoption in medical
devices and monitoring against the necessary regulatory framework.

**Section Responsibilities**

The TGA Medical Devices Auditors undertake assessment of manufacturers of medical
devices for compliance with applicable regulatory requirements and product standards.
These assessments are performed both as on-site audits at the manufactures’ premises, and
off-site reviews of applicable documentation. The TGA relies on audit outcomes from
equivalent international regulatory agencies. In these cases, auditors assess key information
to decide about the manufacturer’s compliance with manufacturing quality requirements.
TGA Medical Devices Auditors also conduct targeted audits in response to potential non
- compliances with manufacturing quality requirements; are active in the International
Medical Device Regulators Forum Medical Device Single Audit Program (MDSAP) and
confidence building activities with the European Commission.

**Key Responsibilities**

Duties within this position are not limited to, but may include:

- Quality Management Systems audits of medical device manufacturing facilities by

onsite audit: Primarily for specific high risk devices overseas and for all risk classes
domestically.
- Conduct all work in accordance with standard operating procedures and within

required timeframes.
- Performing for-cause or targeted audits.
- Quality Management Systems audits of medical device manufacturing facilities by

desktop audit: Using evidence from Comparable Overseas Regulators and directly
from the Sponsor to perform desktop audits.
- Assessments of MDSAP Auditing Organisations [AO) Review of the AO's QMS

documentation.
- On-site assessments for both the AO head office and witnessing AO audits.
- Manage or contribute to project work to develop or improve business processes,

practices, work area capability, policies, guidelines or technical resources.

**Key Capabilities
- An understanding of the Australian regulatory requirements for therapeutic goods,

or the ability to quickly develop this understanding.

procedures, and guidelines to situations involving a high level of complexity and
sensitivity which require considerable interpretation and analysis.
- Well developed written and verbal communication skills.
- Highly developed negotiation, conflict resolution and stakeholder engagement skills

with the capacity to convey complex technical information in a clear and concise
manner.
- Sound judgement, and