In-Demand compliance manager Jobs in drysdale vic

Regulatory Affairs & QMS Manager
VorOtek —Leopold VIC
- From $100,000 a year
- Full-time
- Bachelor's degree
- In-person
- Manufacturing
Quick Apply
9d
Facilities Manager
Cushman & Wakefield —St Albans Park VIC
- Full-time
- Management
- Communication skills
- Hospital experience
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Office Manager
Right at Home Geelong —Geelong West VIC
- $60,000 - $80,000 a year
- Full-time
- Analysis skills
- Organisational skills
- In-person
Quick Apply
Planning and Scheduling Lead
Viva Energy Australia —Corio VIC
- Full-time
- Microsoft Word
- Microsoft Excel
- Maintenance
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1d
Customer Service Consultant | Geelong
Rentokil Initial —Geelong VIC
- Full-time
- Customer service
- Office
- Employee assistance program
- Referral program
Quick Apply
8d
Advanced Practitioner - Geelong
Corrections Victoria —Geelong VIC
- $100,894 - $114,476 a year
- Full-time
- Case management
- Employee assistance program
5d
Community Engagement Coordinator - Geelong
Opendoor —Geelong VIC
- Full-time
- CRM software
- Management
- Microsoft Office
Quick Apply
Senior Workplace Relations and Compliance Advisor (Grade 5), People and Culture
Barwon Health —Geelong VIC
- Part-time
- Working with children
- Organisational skills
- Communication skills
- Employee assistance program
HR & OHSW Coordinator (Corio Campus)
Geelong Grammar School —Geelong VIC
- Part-time
- Microsoft Office
- Administrative experience
- Working with children
Gym Manager
Derrimut 24/7 Gym —Newcomb VIC
- $65,000 - $80,000 a year
- Weekend availability
- Management
- Sales
- Customer service
- Gym membership
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1d
HSEQ Lead & Advisor Opportunities | Melbourne | Major Project | Local / FIFO
Liberty Industrial —Geelong VIC
- Full-time
- Construction
- Communication skills
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Programs Coordinator
City of Greater Geelong —Geelong VIC
- $81,005 a year
- Full-time
- Organisational skills
13d
HR Manager Australia & NZ
VIVESCIA —Geelong VIC
- Management
- ERP systems
- Microsoft Office
Quick Apply
14d
Part Time Customer Service Coordinator
Civilmart - Precast Civil Industries —Corio VIC
- Part-time
- Microsoft Word
- CRM software
- Microsoft Excel
Quick Apply
9d
Project Manager (Grade 5), ICT Infrastructure
Barwon Health —Geelong VIC
- Temporary
- PMP
- No degree
- Communication skills
- Employee assistance program
12d
HSW Specialist - Geelong
The Geelong Clinic —Geelong VIC
- Management
- Clinic
Relief Cook / Community Manager - Geelong (St Albans) Gardens
Ingenia Communities —Geelong VIC
- Leadership
- Communication skills
- Kitchen
- Employee discount
Head Chef/ Chef Manager- Armidale
Compass Group Australia —Geelong VIC
- Full-time
- Culinary experience
- Communication skills
Front Office Manager - Crowne Plaza Geelong
Crowne Plaza Hotels & Resorts —Geelong VIC
- Weekend availability
- Management
- Administrative experience
- Education
7d
Lifestyle Assistant Manager - Ingenia's Lara Lifestyle
Ingenia Communities —Lara VIC
- Full-time
- Remote
- Organisational skills
- Employee discount

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compliance manager jobs near drysdale vic

Regulatory Affairs & QMS Manager

VorOtek
Leopold VIC

Quick Apply

Job Details

Permanent | Full-time
From $100,000 a year
9 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

compliance manager jobs in drysdale vic

Regulatory Affairs & QMS Manager

Facilities Manager

Office Manager

Planning and Scheduling Lead

Customer Service Consultant | Geelong

Advanced Practitioner - Geelong

Community Engagement Coordinator - Geelong

Senior Workplace Relations and Compliance Advisor (Grade 5), People and Culture

HR & OHSW Coordinator (Corio Campus)

Gym Manager

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

Programs Coordinator

HR Manager Australia & NZ

Part Time Customer Service Coordinator

Project Manager (Grade 5), ICT Infrastructure

HSW Specialist - Geelong

Relief Cook / Community Manager - Geelong (St Albans) Gardens

Head Chef/ Chef Manager- Armidale

Front Office Manager - Crowne Plaza Geelong

Lifestyle Assistant Manager - Ingenia's Lara Lifestyle

I want to receive the latest job alert for compliance manager in drysdale vic

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