APS5 Medical Device Quality & Regulatory Officer

Indigeco Pty Ltd; Canberra; On-site; AUD 83,000 - 90,000; Full time

Benefits offered by this job

Hourly pay rate of $60 to $65 per hour

Initial 6-month contract with possible

Chance to gain medical device reg. exp

Job summary

Indigeco Pty Ltd is recruiting an APS5 Medical Device Quality & Regulatory Officer for a Commonwealth Government client in Fairbairn, Canberra. The role supports assessment, evaluation and regulatory compliance of medical devices within Australia’s healthcare regulatory environment.

The successful candidate will review applications, interpret requirements, and prepare evidence-based assessment outcomes. Prior medical device regulation experience is valued but related QA/regulatory backgrounds

Qualifications

• Experience in regulatory affairs, quality assurance, compliance, or related regulatory environments.
• Knowledge of medical device regulation and regulatory submissions.
• Ability to interpret technical documentation and apply regulatory requirements.

Responsibilities

• Undertake regulatory and technical assessments of medical device applications to determine compliance.
• Review registrations, amendments, variations, and consent to supply regulatory activities.
• Prepare evidence-based assessment outcomes and statements of reasons.

Skills

Regulatory affairs

Quality assurance

Compliance

Technical assessments

Healthcare

Medical devices

Biomedical engineering

Scientific environments

Job description

APS5 Medical Device Quality & Regulatory Officer

Indigeco is recruiting an APS5 Medical Device Quality & Regulatory Officer for our Commonwealth Government client based in Fairbairn, Canberra.

This role will support the assessment, evaluation and regulatory compliance of medical devices within Australia's healthcare regulatory environment.

We are seeking a detail-oriented professional with experience in regulatory affairs, quality assurance, compliance, technical assessments, healthcare, medical devices or scientific environments.

The successful candidate will review medical device applications, assess technical documentation, interpret regulatory requirements and prepare evidence-based assessment outcomes.

Previous experience in medical device regulation will be highly regarded, although candidates from broader quality assurance, healthcare, scientific and regulatory backgrounds are encouraged to apply.

ABOUT THE COMPANY

Our client is a Commonwealth Government regulatory organisation responsible for supporting the safety, quality and regulatory oversight of healthcare products and medical devices.

You will join a professional team focused on reviewing technical information, assessing regulatory applications and ensuring medical devices meet relevant legislative and regulatory requirements.

This is an opportunity to contribute to important healthcare regulatory outcomes while developing experience in medical device assessment, regulatory compliance and quality assurance processes.

YOUR RESPONSIBILITIES

• Undertake regulatory and technical assessments of medical device applications, reviewing documentation, supporting evidence and technical data to determine compliance with relevant requirements.
• Review applications relating to medical device registrations, amendments, variations, consent to supply and other regulatory assessment activities.
• Evaluate technical documentation, identify compliance gaps and prepare clear, evidence-based assessment outcomes, recommendations and statements of reasons.
• Interpret and apply relevant legislation, regulatory frameworks, guidelines and policies to support accurate and consistent assessment decisions.
• Prepare high-quality regulatory correspondence, decision letters, notices and communications outlining assessment findings and requirements.
• Liaise with internal stakeholders, technical specialists and applicants to clarify information, communicate assessment requirements and resolve queries.
• Maintain accurate assessment records, manage competing priorities and contribute to continuous improvement across regulatory assessment processes.

YOUR REQUIREMENTS

• You possess a baseline clearance or higher.
• Experience in regulatory affairs, quality assurance, compliance, technical assessments, healthcare, medical devices, biomedical engineering, scientific research or a related environment.
• Strong analytical and critical thinking skills, with the ability to interpret technical documentation, assess information and reach evidence-based conclusions.
• Understanding of quality, compliance, regulatory requirements, technical standards or legislative frameworks within a regulated environment.
• Excellent attention to detail, accuracy and consistency when reviewing documentation, preparing reports and completing assessment activities.
• Strong written communication skills, including the ability to prepare professional reports, assessment findings, technical summaries or regulatory correspondence.
• Strong organisational skills, with the ability to manage multiple applications, changing priorities and competing deadlines while maintaining high-quality outcomes.
• Australian citizenship and the ability to obtain and maintain an Australian Government Baseline security clearance.

DESIRABLE EXPERIENCE

Candidates with experience or qualifications in the following areas will be highly regarded:

• Medical devices, medical technology or biomedical engineering.
• Quality assurance, quality management systems or regulatory compliance.
• Health sciences, biological sciences, biomedical sciences or related scientific disciplines.
• Technical documentation reviews, regulatory submissions or product assessments.
• Understanding of Australian medical device regulatory requirements, including the Therapeutic Goods Act 1989 and Medical Devices Regulations 2002.
• Experience working in healthcare, pharmaceutical, medical technology, scientific or government regulatory environments.

A qualification in a health-related or science-related discipline or biomedical engineering is desirable but not essential.

YOUR PERKS

• Hourly pay rate of $60 to $65 per hour.
• Initial 6-month contract with potential extension of up to 6 months.
• Opportunity to gain experience in medical device regulation, quality and compliance.
• Contribute to important healthcare regulatory outcomes within a Commonwealth Government environment.