Regulatory Affairs Contractor (6-Month Contract) — Frenchs Forest, NSW

Chariot Global is partnering with a confidential global medical device manufacturer to find a Regulatory Affairs Contractor to join their team in Frenchs Forest, NSW.

Contract Type: 6-month contract, with strong potential to extend or convert to a permanent role Location: Frenchs Forest, NSW, Australia — hybrid (1–2 days/week remote, remainder in-office) Industry: Medical Devices

About the Role

Our client is a global medical device company looking for a Regulatory Affairs Contractor to support regulatory activities across the United States, European Union, and Australian markets. This role ensures compliance with TGA regulations, EU MDR, ISO 13485, ISO 14971, and 21 CFR 820, while supporting postmarket surveillance, regulatory impact assessments for product changes, and broader regulatory SME support across a global RA function.

Key Responsibilities

Regulatory Affairs

- Support regulatory strategies by preparing submissions and technical documentation for product approvals in the US, EU, and Australia
- Support regulatory assessments on product or process changes, executing necessary actions such as notifications, new 510(k)s, letters to file, technical file updates, and license amendments
- Review QMS change orders, design change orders, and NCRs to ensure changes don't impact product safety and effectiveness without appropriate regulatory action
- Review labeling and marketing collateral for regulatory compliance, approval conditions,



and consistency of claims with supporting data
- Support regulatory-related CAPAs, driving root cause investigation, action implementation, and effectiveness checks
- Support completion of Health Hazard Evaluations (HHEs) and partner with Corporate Shared Services to manage field actions and recalls

Business Collaboration

- Partner with cross-functional teams to ensure projects and initiatives meet regulatory and quality requirements
- Align local RA activities with global policies and standards

Qualifications, Skills & Experience
- Bachelor's degree in science, biomedical engineering, regulatory affairs, or a related field
- 2–3 years' experience in Regulatory Affairs within medical devices, healthcare, or a related industry is desirable
- Experience working on software-based medical device products is highly desirable
- Strong analytical skills — able to synthesize complex or diverse information with a keen attention to detail
- Sound problem-solving skills, gathering and analyzing information to develop practical alternatives
- Clear, persuasive oral and written communication skills
- A quality-first mindset with a track record of accuracy and thoroughness
- Self-starter who manages day-to-day tasks independently while collaborating to meet deadlines
- Solid business acumen and sound, inclusive judgment
- Emotional intelligence to navigate complex, sometimes high-pressure situations professionally
- Commitment to safety, security, and a respectful, harassment-free workplace

📌 Regulatory Affairs Consultant (Frenchs Forest)
🏢 Chariot Global (A BrickRed Group
📍 Frenchs Forest