Regulatory Affairs Lead Consultant

BrickRed Systems; Sydney; On-site; AUD 83,000 - 152,000; Full time

Job summary

BrickRed Systems is seeking an experienced Regulatory Affairs Contractor to support a global medical device portfolio from its NSW location. The role covers regulatory activities across the US, EU, and Australian markets, ensuring compliance with TGA, EU MDR, ISO 13485, ISO 14971, and 21 CFR 820.

You will prepare regulatory submissions, assess changes, and manage technical documentation, labeling reviews, and post-market surveillance while coordinating with cross-functional teams to ensure

Qualifications

• 2–3 years in Regulatory Affairs, preferably in medical devices.
• Bachelor's degree in Science, Biomedical Engineering, Regulatory Affairs, or 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 510(k)s, Letters to File, 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.

Responsibilities

• 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 regulatory actions are identified and completed when changes may affect product safety, labeling, or regulatory status.
• Review labeling, promotional materials, and marketing collateral for regulatory compliance and data-supported claims.
• Support post-market surveillance activities and regulatory input into safety and compliance assessments.
• Support regulatory-related CAPAs and Health Hazard Evaluations (HHEs).
• Partner with cross-functional stakeholders to support field actions, recalls, and other regulatory activities.

Skills

Regulatory Affairs

Medical devices

Global markets

Regulatory submissions

QMS ISO13485

Education

Bachelor's degree in Science/Engineering

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 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
• 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.