We are seeking an experiencedRegulatory Affairs Contractorto join aglobal medical device manufacturerin Frenchs Forest, NSW.
The ideal candidate will support regulatory activities across theUnited States, European Union, and Australian markets, ensuring compliance with applicable regulatory requirements and quality standards.
This role will provide regulatory support acrossTGA regulations, EU MDR, ISO *****, ISO *****, and 21 CFR 820, while contributing topost-market surveillance, regulatory impact assessments, product and process changes, submissions, technical documentation, and global Regulatory Affairs activities.
Required Skills & Experience
2–3 years of experience in Regulatory Affairs, preferably withinmedical devices, healthcare, or a related industry
Bachelor's degree inScience, Biomedical Engineering, Regulatory Affairs, or a related field
Experience supporting regulatory activities acrossUS, EU, and Australian markets
Strong knowledge ofTGA regulations, EU MDR, ISO *****, ISO *****, and 21 CFR 820
Experience preparing or supportingregulatory submissions and technical documentation
Experience withpost-market surveillance and regulatory impact assessments
Knowledge ofproduct/process change assessments, including regulatory notifications, new510(k)s, Letters to File, technical file updates, and license amendments
Experience reviewingQMS change orders, design change orders, and NCRsfor regulatory impact
Experience reviewingproduct labeling and marketing collateralfor regulatory compliance and claims consistency
Strong analytical, problem-solving, and decision-making skills
Excellent written and verbal communication skills




Robust attention to detail with aquality-first mindset
Ability to work independently, manage priorities, and meet deadlines
Strong business acumen and sound, inclusive judgment
High level ofemotional intelligenceand ability to work effectively in complex or high-pressure situations
Commitment tosafety, security, quality, and a respectful workplace
Key Responsibilities
Regulatory Affairs
Supportglobal regulatory strategiesby preparing regulatory submissions and technical documentation for product approvals across theUS, EU, and Australia.
Conductregulatory assessments for product and process changesand execute appropriate regulatory actions.
Support regulatory activities includingnotifications, new 510(k)s, Letters to File, technical file updates, and license amendments.
ReviewQMS change orders, design change orders, and NCRsto determine potential regulatory impact on product safety and effectiveness.
Ensure appropriate regulatory actions are identified and completed when changes may affectproduct safety, effectiveness, labeling, or regulatory status.
Reviewlabeling, promotional materials, and marketing collateralfor regulatory compliance, approval conditions, and consistency of product claims with supporting data.




Supportpost-market surveillance activitiesand provide regulatory input into safety and compliance assessments.
Supportregulatory-related CAPAs, including root cause investigations, action implementation, and effectiveness checks.
Support completion ofHealth Hazard Evaluations (HHEs)and related regulatory assessments.
Partner with Corporate Shared Services and cross-functional stakeholders to supportfield actions, recalls, and other regulatory activities.
ProvideRegulatory Affairs subject matter expertiseacross the broader global RA function.
Maintain accurate and complete regulatory documentation in accordance with applicable procedures and requirements.
Key Regulatory Areas
TGA | EU MDR | FDA / 510(k) | ISO ***** | ISO ***** | 21 CFR 820 | Post-Market Surveillance | CAPA | Health Hazard Evaluations | Field Actions & Recalls | Regulatory Change Assessments | Technical Documentation | Labeling & Claims
ABOUT BRICKRED SYSTEMS
BrickRed Systems is a global leader in next-generation technology consulting and workforce solutions, specializing in delivering high-quality talent acrossdigital, engineering, healthcare, analytics, finance, operations, and business transformation domains.
With a strong emphasis on innovation, scalability, and client success, BrickRed Systems helps organizations solve complex business challenges by providing skilled professionals across strategy, technology, creative, and operational functions.
BrickRed Systems fosters a culture ofcontinuous learning, collaboration, and excellence, enabling professionals to contribute to high-impact global initiatives while advancing their careers.
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📌 Regulatory Affairs Lead Consultant (Brisbane)
🏢 BrickRed Systems
📍 Brisbane