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
