Job Description
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




Good to Have
Experience working with software-based medical device products
Experience supporting regulatory CAPAs
Experience with Health Hazard Evaluations (HHEs)
Exposure to field actions and product recalls
Experience working within a global Regulatory Affairs organization
Experience partnering with cross-functional Quality, Engineering, Clinical, Marketing, and Operations teams
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.
Business Collaboration
Partner with cross-functional teams to ensure projects, product changes, and business initiatives meet regulatory and quality requirements.
Collaborate with Quality, Engineering, Product Development, Marketing, Operations, and other stakeholders on regulatory assessments and compliance activities.
Align local Regulatory Affairs activities with global policies, procedures, regulatory strategies, and standards.
Communicate regulatory requirements, risks, and recommendations clearly to internal stakeholders.
Provide practical, risk-based regulatory guidance to support business objectives while maintaining patient safety, product quality, and regulatory compliance.
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 robust 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.

📌 Regulatory Affairs Lead Consultant (New South Wales)
🏢 BrickRed Systems
📍 New South Wales