In-Demand Of regulatory affairs Jobs in Victoria

Regulatory Affairs & QMS Manager
VorOtek —Leopold VIC
- From $100,000 a year
- Full-time
- Bachelor's degree
- In-person
- Manufacturing
Quick Apply
10d
Regulatory Affairs Manager
Chobani —Dandenong VIC
- Full-time
- Parental leave
13h
Regulatory Affairs & Quality Specialist
Steris —Melbourne VIC
- Full-time
- English
- Microsoft Office
- SharePoint
Regulatory Officer
Department of Government Services —Melbourne VIC
- $62,104 - $70,930 a year
- Full-time
- Computer skills
- Communication skills
9d
Associate Director, Regulatory Affairs
CSL Seqirus —Melbourne VIC
- Full-time
- Hybrid work
- Writing skills
- Leadership
- Communication skills
14d
Senior Associate, Regulatory Breach Reporting
AustralianSuper —Melbourne VIC
- Full-time
- Microsoft Excel
- Finance
- Analysis skills
Junior/Mid Legal Counsel
Heidi —Melbourne VIC
- Full-time
- Hybrid work
- AI
- Parental leave
Clinical Research Associate (Contractor) Australia
Allucent —Melbourne VIC
- Part-time
- Patient monitoring
Quick Apply
Senior Manager - Sustainability
Orica —East Melbourne VIC
- Full-time
7d
Regulatory Manager
Nu-Mega Ingredients Pty Ltd —Altona North VIC
- Full-time
- Hybrid work
Quick Apply
RRP SOURCING SUSTAINABILITY MANAGER
JTI —Research VIC
- English
- Master's degree
- Communication skills
8d
Packaging & Sustainability Technologist
Wesfarmers Health —Docklands VIC
- Engineering
- Bachelor's degree
- Employee assistance program
Sr Product Manager, Cell Therapy
Gilead Sciences —Melbourne VIC
- Full-time
- Analysis skills
- Leadership
Government Relations Coordinator
Australia Pacific Airports (Melbourne) —Melbourne VIC
- Full-time
- Hybrid work
- Bachelor's degree
- Communication skills
- Employee assistance program
General Counsel
Victorian Disability Worker Commission —Melbourne VIC
- $142,790 - $191,084 a year
- Full-time
- Management
- Recruiting
12h
Marketing Compliance Coordinator
Aussie Broadband —Melbourne VIC
- Full-time
- Microsoft Office
- Annual leave
- Parental leave
10d
Senior Solicitor, CAV Underquoting Taskforce
Department of Government Services —Melbourne VIC
- $116,413 - $140,849 a year
- Full-time
1d
Head of Media
Bolster Digital —Melbourne VIC
- Full-time
- Hybrid work
- Management
- Business development
- Presentation skills
- Employee assistance program
Quality Specialist
Wesfarmers Health —Docklands VIC
- Contract
- Microsoft Office
- Databases
- Bachelor's degree
- Employee assistance program
9d
Consultant / Senior Consultant, Company and Personal Insolvency
Teneo —Melbourne VIC
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel

I want to receive the latest job alert for of regulatory affairs in victoria

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

of regulatory affairs jobs near victoria

Senior Product Manager jobs in Melbourne VIC

Solicitor jobs in Melbourne VIC

Compliance Officer jobs in Melbourne VIC

Senior Reporting Analyst jobs in Melbourne VIC

General Counsel jobs in Melbourne VIC

Senior Product Manager jobs in Sydney Nsw

Nurse Manager jobs in Melbourne Vic

Project Manager Council jobs in Sydney Nsw

Environmental Manager jobs in Sydney Nsw

Environmental Sustainability jobs in Sydney Nsw

Practice Manager jobs in Brisbane Qld

Environmental Manager jobs in Melbourne Vic

Environmental Manager jobs in Fremantle Wa

Maintenance Manager jobs in Perth Wa

Internship, Environmental Science jobs in Newcastle Nsw

Environmental Manager jobs in Wanneroo Wa

Legal Counsel jobs in Sydney Nsw

Legal Counsel jobs in Brisbane Qld

Legal Counsel Senior Legal Counsel jobs in Brisbane Qld

Legal In House Counsel Remote jobs in Sydney Nsw

Regulatory Affairs & QMS Manager

VorOtek
Leopold VIC

Quick Apply

Job Details

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

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

of regulatory affairs jobs in victoria

Regulatory Affairs & QMS Manager

Regulatory Affairs Manager

Regulatory Affairs & Quality Specialist

Regulatory Officer

Associate Director, Regulatory Affairs

Senior Associate, Regulatory Breach Reporting

Junior/Mid Legal Counsel

Clinical Research Associate (Contractor) Australia

Senior Manager - Sustainability

Regulatory Manager

RRP SOURCING SUSTAINABILITY MANAGER

Packaging & Sustainability Technologist

Sr Product Manager, Cell Therapy

Government Relations Coordinator

General Counsel

Marketing Compliance Coordinator

Senior Solicitor, CAV Underquoting Taskforce

Head of Media

Quality Specialist

Consultant / Senior Consultant, Company and Personal Insolvency

I want to receive the latest job alert for of regulatory affairs in victoria

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected