Post-Market Quality & Regulatory Specialist

Stryker; Redmond; On-site; AUD 119,000 - 198,000; Full time

Job summary

Stryker is seeking a Quality Assurance Post Market Specialist to help ensure the safety, quality, and effectiveness of its medical devices. You will collaborate with Quality, Engineering, Clinical, and Marketing teams to support regulatory decisions and assist with technical documentation and submissions.

Responsibilities include reviewing complaints and adverse events, supporting product field actions, and maintaining awareness of global post-market surveillance regulations.

Qualifications

• Bachelor's degree required.
• 0–2 years in post-market surveillance, quality, regulatory affairs, clinical, or related field.
• Strong verbal and written communication skills.
• Analytical, organizational, and problem-solving abilities.
• Ability to write, review, and edit technical documentation.

Responsibilities

• Support post-market surveillance to ensure regulatory compliance.
• Review product complaints and adverse events for reportability and patient harm.
• Interface with customers to collect adverse event details.
• Collect, analyze, and report post-market data to regulators and stakeholders.
• Support Field Action and Medical Risk Assessment activities.
• Contribute to CAPA, nonconformance investigations, and audit responses.
• Assist in technical documentation and regulatory submissions.

Skills

Verbal communication

Written communication

Analytical thinking

Cross-functional collaboration

Documentation editing

Education

Bachelor's degree

Tools

Microsoft Office (Word, Excel)

Job description

Stryker is seeking a Quality Assurance Post Market Specialist to help ensure the safety, quality, and effectiveness of its medical devices. You will collaborate with Quality, Engineering, Clinical, and Marketing teams to support regulatory decisions and assist with technical documentation and submissions.

Responsibilities include reviewing complaints and adverse events, supporting product field actions, and maintaining awareness of global post-market surveillance regulations.