We are seeking an experienced

Regulatory Affairs Contractor

to join a

global medical device manufacturer

in Frenchs Forest, NSW. The ideal candidate will support regulatory activities across the

United States, European Union, and Australian markets , ensuring compliance with applicable regulatory requirements and quality standards.

This role will provide regulatory support across

TGA regulations, EU MDR, ISO 13485, ISO 14971, and 21 CFR 820 , while contributing to

post-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 within

medical devices, healthcare, or a related industry

Bachelor's degree in

Science, Biomedical Engineering, Regulatory Affairs, or a related field

Experience supporting regulatory activities across

US, EU, and Australian markets

Strong knowledge of

TGA regulations, EU MDR, ISO 13485, ISO 14971, and 21 CFR 820

Experience preparing or supporting

regulatory submissions and technical documentation

Experience with

post-market surveillance and regulatory impact assessments

Knowledge of

product/process change assessments , including regulatory notifications, new

510(k)s , Letters to File, technical file updates, and license amendments

Experience reviewing

QMS change orders, design change orders, and NCRs

for regulatory impact

Experience reviewing

product labeling and marketing collateral

for regulatory compliance and claims consistency

Strong analytical, problem-solving, and decision-making skills

Excellent written and verbal communication skills





Strong attention to detail with a

quality-first mindset

Ability to work independently, manage priorities, and meet deadlines

Robust business acumen and sound, inclusive judgment

High level of

emotional intelligence

and ability to work effectively in complex or high-pressure situations

Commitment to

safety, security, quality, and a respectful workplace

Key Responsibilities Regulatory Affairs

Support

global regulatory strategies

by preparing regulatory submissions and technical documentation for product approvals across the

US, EU, and Australia .

Conduct

regulatory assessments for product and process changes

and execute appropriate regulatory actions.

Support regulatory activities including

notifications, new 510(k)s, Letters to File, technical file updates, and license amendments .

Review

QMS change orders, design change orders, and NCRs

to determine potential regulatory impact on product safety and effectiveness.

Ensure appropriate regulatory actions are identified and completed when changes may affect

product safety, effectiveness, labeling, or regulatory status .

Review

labeling, promotional materials, and marketing collateral

for regulatory compliance, approval conditions, and consistency of product claims with supporting data.

Support

post-market surveillance activities





and provide regulatory input into safety and compliance assessments.

Support

regulatory-related CAPAs , including root cause investigations, action implementation, and effectiveness checks.

Support completion of

Health Hazard Evaluations (HHEs)

and related regulatory assessments.

Partner with Corporate Shared Services and cross-functional stakeholders to support

field actions, recalls, and other regulatory activities .

Provide

Regulatory Affairs subject matter expertise

across 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 13485 | ISO 14971 | 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 across

digital, 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 of

continuous 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