In-Demand Audit manager Jobs in Geelong, Vic

Regulatory Affairs & QMS Manager
VorOtek —Leopold VIC
- From $100,000 a year
- Full-time
- Bachelor's degree
- In-person
- Manufacturing
Quick Apply
genU Group Payroll Manager
genU —Geelong VIC
- $143,748 - $160,405 a year
- Full-time
- Hybrid work
- Management
- Administrative experience
- University
- Employee assistance program
- Referral program
11d
Asset Management Analyst
City of Greater Geelong —Geelong VIC
- $109,342.91 a year
- Full-time
- Business
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Liberty Industrial —Geelong VIC
- Full-time
- Construction
- Communication skills
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Maintenance Manager
Vossloh Sleeper Technologies Australia Pty Ltd —Geelong VIC
- Full-time
- Microsoft Word
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- Parental leave
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Chef Manager
Bupa —Belmont VIC
- Full-time
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Nurse Unit Manager, Immunisation, Public Health
Barwon Health —Geelong VIC
- Full-time
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Ridley Corporation —Lara VIC
- Full-time
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Ridley Corporation —Lara VIC
- Overtime
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genU Group Payroll Manager
genU —Geelong VIC
From disability and aged care support to community-focused initiatives, we’re here to help people live their best lives. Date Posted: 3 Jun 2026.
$143,748 - $160,405 a year
11d

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Regulatory Affairs & QMS Manager

VorOtek
Leopold VIC

Quick Apply

Job Details

Permanent | Full-time
From $100,000 a year

Qualifications

Mechanical Engineering
Bachelor's degree
Manufacturing
Document management systems
Leadership
FDA regulations

Full Job Description

About VorOtek

VorOtek Pty Ltd is an Australian medical device manufacturer specialising in innovative head-worn illumination and visualisation systems & associated medical devices.

As we expand across Australia, Europe, the UK and North America, we are strengthening our regulatory and quality capabilities to support domestic & international growth, product innovation and compliance excellence.

The Opportunity

We are seeking an experienced Regulatory Affairs & QMS Manager to lead and evolve VorOtek's Regulatory Affairs and Quality Management System.

The successful candidate must have a minimum of 2-3 years of regulatory affairs experience specifically within the medical device manufacturing sector. As well as have acquired appropriate tertiary qualifications, such as a Bachelor or Biomedical Engineering, Mechanical Engineering, Life Sciences, Physical Sciences or a highly relevant field, along with ISO 13485 and medical device regulation training/certification.

This is a full-time and on-site leadership role based at our Geelong manufacturing facility, with cross-functional influence and responsibility for ensuring global regulatory and ISO 13485 QMS compliance.

You will work closely with leadership, engineering, production and commercial teams to ensure our products meet the highest standards of safety, performance and regulatory compliance.

Key Responsibilities

Lead Regulatory Affairs & Market Compliance
Own and implement regulatory compliance across Australia (TGA), EU (MDR), UK (UKCA), USA (FDA) and other target markets
Prepare, submit and maintain medical device registrations including technical documentation
Ensure ongoing registration compliance including classification, essential principles, GSPR, labelling, IFU, declarations of conformity and post-market surveillance
Monitor regulatory changes and assess impact on products and business operations
Act as primary liaison with regulators, notified bodies and external consultants
Lead Quality Management to achieve and maintain ISO 13485 compliance
Develop, implement and maintain all QMS documentation
Oversee document control systems
Own and manage all internal & external QMS audit programs
Ensure supplier qualification and monitoring processes are compliant
Support product lifecycle quality activities including design & production controls, verification/validation, and change control
Own and manage all risk management (ISO 14971) activities
Ensure post-market surveillance processes are implemented and maintained
Drive & support CAPA processes
Deliver QMS training & collaborate cross-functionally across the organisation
Establish and monitor quality KPIs, providing regular reporting
Demonstrate proven experience in ISO 13485 implementation within a medical device environment

Key Skills

Proven experience in Regulatory Affairs and Quality Management Systems (ISO 13485) within the medical device industry
Strong working knowledge of:
ISO 13485 & ISO 14971
International regulations including TGA, MDR, FDA, UKCA.
Demonstrated experience preparing technical documentation and regulatory submissions
Experience managing or significantly contributing to QMS (ISO 13485) in a medical device environment
Strong technical writing skills & attention to detail
Ability to work independently and cross-functionally
Experience with audit leadership and regulatory inspections

Pay: From $100,000.00 per year

Work Location: In person

Quick Apply

Refine Your Search

audit manager jobs in geelong, vic

Regulatory Affairs & QMS Manager

genU Group Payroll Manager

Asset Management Analyst

HSEQ Lead & Advisor Opportunities | Melbourne | Major Project | Local / FIFO

Maintenance Manager

Chef Manager

Nurse Unit Manager, Immunisation, Public Health

Warehouse and Laboratory Officer

Maintenance - Electrician

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