Regulatory Medical Device Assessor – Canberra Contract (6m)

RELATBL Recruiting Pty Ltd; Canberra; Hybrid; AUD 76,000 - 96,000; Full time

Benefits offered by this job

Competitive remuneration

Employee Assistance Program

Job summary

relatbl Recruiting is seeking an APS5 level regulator to assess medical device applications for a Commonwealth Government regulator, based in Canberra. You will evaluate technical documentation and data to deliver evidence-based decisions that support safe devices entering the Australian market.

This full-time role (37.5 hours/week) offers flexible working arrangements and a 6-month contract with possible extension.

Qualifications

• Ability to interpret and apply legislation, regulatory frameworks and guidelines, and analyse technical information to prepare clear regulatory decisions.
• High level of attention to detail, accuracy and consistency.
• Strong communication skills and the ability to work collaboratively with multiple stakeholders.
• Ability to manage multiple deadlines and competing priorities, and adapt to changing regulations and priorities.
• Desirable: health, science or biomedical engineering qualification and/or medical device assessment experience.

Responsibilities

• Assess medical device applications and changes by evaluating technical documentation and data.
• Prepare clear, evidence-based assessment outcomes and statements of reasons.
• Provide timely advice on medical device regulatory requirements and legislation.
• Build productive stakeholder relationships and give feedback on assessment outcomes.
• Maintain accurate records and contribute to process improvement initiatives.

Job description

relatbl Recruiting is seeking an APS5 level regulator to assess medical device applications for a Commonwealth Government regulator, based in Canberra. You will evaluate technical documentation and data to deliver evidence-based decisions that support safe devices entering the Australian market.

This full-time role (37.5 hours/week) offers flexible working arrangements and a 6-month contract with possible extension.