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
- Solid 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 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.

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