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 *****, ISO *****, 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 *****, ISO *****, 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
Strong 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 ***** | 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 across
digital, engineering, healthcare, analytics, finance, operations, and business transformation domains
. With a solid 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.
#J-*****-Ljbffr

📌 Regulatory Affairs Lead Consultant (Brisbane)
🏢 BrickRed Systems
📍 Brisbane