Job Description

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APS6 Medical Devices Audit Case Manager

Advertiser: Randstad - CommercialMore jobs from this company

Job Information

Job Listing Date
4 Jan 2021
Location
ACT
Salary
$85,088 - $95,993
Work Type
Full Time
Classification
Government & Defence, Government - Federal

APS6 Medical Devices Audit Case Manager

Randstad is exclusively working with the Theraputic Goods Administration to support their recruitment processes in the Medical Devices Branch. Please follow the link at the bottom of the page to lodge your application directly with the Department.

About the Health Products Regulation Group

Regulation that protects and enhances the health and safety of the community is a major component of a high quality health system. The Health Products Regulation Group supports timely access to products that will help achieve better health and wellbeing, whilst checking that these products do not themselves put Australians' health and safety at risk. We achieve this through regulation of therapeutic goods and certain controlled drugs and drug substances. This applies to all such goods exported, imported, supplied and manufactured in Australia.

The Opportunity

Medical Devices Audit Case Manager APS6 - (Ongoing, Non-ongoing, Fulltime, Part-Time)

Devices Quality Audits and Assessment Section

Medical Devices Auditors undertake assessment of manufacturers of medical devices for compliance with applicable regulatory requirements and product standards. 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.

Skills Required

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

  • Business planning and scheduling work for the team - in particular Audit Program Scheduling.
  • Triaging of referrals for audit and assessment
  • Entering and retrieval of audit related information held in the HPRG's business systems. Production of business activity reports.
  • Record keeping and record management of official decisions and actions in accordance with the Department of Health's record management protocols. Help produce and maintain the Branch Quality Management Systems procedures, templates and records.
  • Coordinating domestic and international travel for DQAAS auditors, and international trips undertaken by other TGA staff each year. Travel for audits, national and international business and Standards committee and working group meetings.
  • Using HPRG financial systems to generate invoices for the recovery of the cost of audits and audit related travel.
  • Providing a key point of contact between the Device Quality Audits and Assessment Section, other units within the Department and its external customers (i.e. Manufacturers and suppliers of medical devices) and ndertake and manage escalated and/or complex compliance investigations, and promote and encourage compliance assessment and decision making in line with best practice frameworks
  • Undertaking business planning and scheduling work for the team
  • Conducting and managing compliance case management and/or monitoring activities to assess regulated products and/or services for compliance with regulatory requirements.
  • Providing timely technical/professional advice to internal and external stakeholders.
  • Record keeping and record management of official decisions and actions in accordance with the Department of Health's record management protocols
  • Participating in providing quality improvement in regulatory processes and reform in key areas, according to government priorities
  • Positively contribute to representing the TGA at various internal and external meetings as necessary to fulfil the TGA's functions as the national regulator of the therapeutic goods as required
  • Contributing to broader organisational objectives by undertaking other tasks as required
  • Contributing to a positive, collaborative and diverse workplace culture in line with the APS Code of Conduct and iCare Values.

Please note, this vacancy will be open for applications until Monday 11 January 2021 and interviews will be held in early 2021.

We seek people with a wide variety of skills and competencies, and look for applicants who demonstrate they will strive to support the behaviours we seek to foster in our workforce. We are an inclusive employer and promote, value and support diversity among our employees with the aim of ensuring our workforce reflects, respects and benefits from diverse communities including Indigenous Australians, people from culturally and linguistically diverse backgrounds, LGBTQI+ and people with disability.

Eligibility

To be eligible for employment with the Department of Health 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).
  • For this role applicants must be able to obtain and maintain a Baseline security clearance, or hold a current security clearance of an appropriate level.

For further enquiries about these vacancies please contact:

Taylor Dudley - Scribing and Campaign Manager, Federal Government

02 6132 3816 | Taylor.Dudley@randstad.com.au

Please submit your application directly with the Department. Randstad are not accepting applications directly but are the main point of contact for any questions or queries with regards to this process. Copy and paste the below link into your browser to apply!

shorturl.at/iorRY

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

randstad.com.au

Randstad is exclusively working with the Theraputic Goods Administration to support their recruitment processes in the Medical Devices Branch. Please follow the link at the bottom of the page to lodge your application directly with the Department.

About the Health Products Regulation Group

Regulation that protects and enhances the health and safety of the community is a major component of a high quality health system. The Health Products Regulation Group supports timely access to products that will help achieve better health and wellbeing, whilst checking that these products do not themselves put Australians' health and safety at risk. We achieve this through regulation of therapeutic goods and certain controlled drugs and drug substances. This applies to all such goods exported, imported, supplied and manufactured in Australia.

The Opportunity

Medical Devices Audit Case Manager APS6 - (Ongoing, Non-ongoing, Fulltime, Part-Time)

Devices Quality Audits and Assessment Section

Medical Devices Auditors undertake assessment of manufacturers of medical devices for compliance with applicable regulatory requirements and product standards. 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.

Skills Required

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

  • Business planning and scheduling work for the team - in particular Audit Program Scheduling.
  • Triaging of referrals for audit and assessment
  • Entering and retrieval of audit related information held in the HPRG's business systems. Production of business activity reports.
  • Record keeping and record management of official decisions and actions in accordance with the Department of Health's record management protocols. Help produce and maintain the Branch Quality Management Systems procedures, templates and records.
  • Coordinating domestic and international travel for DQAAS auditors, and international trips undertaken by other TGA staff each year. Travel for audits, national and international business and Standards committee and working group meetings.
  • Using HPRG financial systems to generate invoices for the recovery of the cost of audits and audit related travel.
  • Providing a key point of contact between the Device Quality Audits and Assessment Section, other units within the Department and its external customers (i.e. Manufacturers and suppliers of medical devices) and ndertake and manage escalated and/or complex compliance investigations, and promote and encourage compliance assessment and decision making in line with best practice frameworks
  • Undertaking business planning and scheduling work for the team
  • Conducting and managing compliance case management and/or monitoring activities to assess regulated products and/or services for compliance with regulatory requirements.
  • Providing timely technical/professional advice to internal and external stakeholders.
  • Record keeping and record management of official decisions and actions in accordance with the Department of Health's record management protocols
  • Participating in providing quality improvement in regulatory processes and reform in key areas, according to government priorities
  • Positively contribute to representing the TGA at various internal and external meetings as necessary to fulfil the TGA's functions as the national regulator of the therapeutic goods as required
  • Contributing to broader organisational objectives by undertaking other tasks as required
  • Contributing to a positive, collaborative and diverse workplace culture in line with the APS Code of Conduct and iCare Values.

Please note, this vacancy will be open for applications until Monday 11 January 2021 and interviews will be held in early 2021.

We seek people with a wide variety of skills and competencies, and look for applicants who demonstrate they will strive to support the behaviours we seek to foster in our workforce. We are an inclusive employer and promote, value and support diversity among our employees with the aim of ensuring our workforce reflects, respects and benefits from diverse communities including Indigenous Australians, people from culturally and linguistically diverse backgrounds, LGBTQI+ and people with disability.

Eligibility

To be eligible for employment with the Department of Health 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).
  • For this role applicants must be able to obtain and maintain a Baseline security clearance, or hold a current security clearance of an appropriate level.

For further enquiries about these vacancies please contact:

Taylor Dudley - Scribing and Campaign Manager, Federal Government

02 6132 3816 | Taylor.Dudley@randstad.com.au

Please submit your application directly with the Department. Randstad are not accepting applications directly but are the main point of contact for any questions or queries with regards to this process. Copy and paste the below link into your browser to apply!

shorturl.at/iorRY

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

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