Senior QA & Regulatory Lead - Medical Devices (ANZ)

GN Hearing Australia; Ryde; On-site; AUD 120,000 - 160,000; Full time

Benefits offered by this job

Digital reward platform with discounts

Wellbeing webinars

Volunteer leave

Discounts on GN products

Birthday gift

Free annual flu vaccinations

Onsite fruit and refreshments

Job summary

GN Hearing Australia in Sydney is seeking a Senior Quality Assurance Specialist to drive ISO13485 compliance, regulatory submissions, and quality processes across Australia and New Zealand. You will lead internal audits, CAPA boards, and liaison with global QA/RA teams.

Join a high-performing Operations team with opportunities to implement process improvements, risk management and supplier qualification while uplifting regulatory knowledge across the business.

Qualifications

• Minimum 4 years’ experience with ISO13485 in a medical device production environment.
• Strong knowledge of Australian medical device regulations (TGA).
• Hands-on experience in auditing, process validation, and risk assessment.
• Excellent communication skills, with the ability to influence at all levels.
• A science, biochemistry, or related degree.
• Experience with TGA Advertising Code compliance.
• Additional training in validation, biocompatibility, or risk assessment
• Product Quality Engineering experience.

Responsibilities

• Lead and manage day-to-day Quality and Regulatory requirements for the ANZ business.
• Act as the local Subject Matter Expert for ISO13485 and quality processes, driving compliance across the organisation.
• Conduct internal audits, coordinate Management Reviews, and lead CAPA board meetings.
• Oversee custom product validation and spreadsheet validation activities.
• Partner with global QA/RA teams on process improvements and issue resolution.
• Manage ANZ vigilance reporting, complaints handling, and regulatory submissions.
• Train colleagues on quality and regulatory requirements to uplift knowledge across the business.
• Provide expert input into risk assessments, supplier qualification, and continuous improvement initiatives.

Skills

ISO13485 experience

Auditing

Regulatory knowledge

Risk assessment

Communication

Education

Science/biochemistry degree

Job description

GN Hearing Australia in Sydney is seeking a Senior Quality Assurance Specialist to drive ISO13485 compliance, regulatory submissions, and quality processes across Australia and New Zealand. You will lead internal audits, CAPA boards, and liaison with global QA/RA teams.

Join a high-performing Operations team with opportunities to implement process improvements, risk management and supplier qualification while uplifting regulatory knowledge across the business.