Job Description

1. Job Description
Title: Quality Assurance & Regulatory Affairs Manager
Reporting to: Service and Quality Director – Local
Functional Reporting to: ASPAC Quality Director, Quality ASPAC
Responsible for: The overall company performance in meeting the ISO 9001 standard and
the overall compliance of the company’s processes and products to any
mandatory or elective regulatory/quality requirement set by the organization
Supervises: Refer Organisation Chart F097
Workplace Health & Safety: All Managers and Supervisors are accountable and responsible for the
implementation of the bioMérieux Workplace Health and Safety Policy and
any procedures developed to aid its intent.
Accountable For:
In this role, The QARA Manager shall be:
1. Managing Quality and Regulatory functions.
2. Sharing Global, Regional, Standards , regulatory expectations with the direct report.
3. Functioning in a hybrid role (QA/RA)
4. Reporting to the Service & Quality Director.
Quality Assurance
Conducting internal audits and escalating to the Service & Quality Director.
Implementing the recommendations from internal and external audits on the quality system.
Ensuring all systems and Processes are documented to meet internal and external requirements.
Ensuring any activity within the company meets set requirements or standards. (ISO9001)
Communicating and liaising with global and regional staff.
Participate in the relevant Quality-related committees-ASPAC
Report on and recommend changes to company processes or outcomes where necessary
Managing and maintaining all aspects of the Quality Management System
Performing other duties and responsibilities as required.
Monitoring Quality KPI’s such as CAPA (trackwise),Technical complaints, Non-technical complaints, NCRs
and Goods on Hold review then discussing with the Service & Quality Director.
Discussing issues around all aspects of the business and assisting the business by problem solving. Hands-
on, action-oriented, and able to implement effectively through his/her team.
Regulatory Affairs
Ownership for all regulatory activities across the Australian market.
Liaison with Regional and Global stakeholders.
Develop strong relationships with the TGA, Medsafe and other relevant regulatory entities and
associations
Regulatory strategy development responsibility in collaboration with the Marketing team.
Maintaining Regulatory Affairs database (RADB)
Pre-Market Activities
Product Registrations - Overseeing regulatory and corporate deadlines
Import Permits
ERAC
Post Market Activities
Recalls
Field actions
Adverse event reporting
LL No. 026619 102/08/0513
Page 1 of 2
bioMérieux Australia Pty Ltd
NB: Job Descriptions will be updated to reflect changes in Responsibilities and Duties as they occur.

2. Job Description
Measurements:
Internal & External audit results/ outcome.
QARA KPI’s (Technical complaints, Field Actions, CAPA, Adverse events Reporting (AER), Recalls,
Product registrations, quality score card and Calibrations),
Compliance to regulations
Personal MBO’s.
HR measurements & staff feedback (eg turnover, training, etc)
Skills/Educational Requirements:
Previous experience with Quality systems (ISO9001:2015) and regulatory and Statutory Compliance
Good organisational and communication skills
Computer literacy including Microsoft Office
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
Continuous improvement minded; familiar with balancing the need for Quality and the need
for efficiency
Direct and positive experience in communicating with Regulatory Authorities and Distributors.
Has experience using SAP, trackwise and Centralised QMS database such as
Livelink, AGILE.
LL No. 026619 102/08/0513
Page 2 of 2
bioMérieux Australia Pty Ltd
NB: Job Descriptions will be updated to reflect changes in Responsibilities and Duties as they occur.