? Location: Macquarie Park, NSW

? Employment Type: 12 months contract+ Extension

About the Role

We are seeking a detail-oriented Regulatory Affairs Specialist to support regulatory activities associated with medical devices. This role is responsible for coordinating and preparing regulatory submissions, maintaining regulatory documentation, ensuring compliance with global regulatory requirements, and supporting regulatory inspections and audits.

The successful candidate will work closely with cross-functional teams to ensure timely submissions, maintain regulatory records, and contribute to the successful execution of regulatory strategies.

Key Responsibilities

- Coordinate and prepare documentation packages for regulatory submissions.
- Compile, review, and submit regulatory documentation in accordance with applicable regulations and internal procedures.
- Maintain and update regulatory approval data within internal systems to ensure accuracy and compliance.
- Monitor regulatory submission timelines and improve document tracking and control processes.
- Support internal and external regulatory audits and inspections.
- Collaborate with Quality, R&D;, Clinical, Manufacturing, and other cross-functional teams to gather submission materials.
- Stay informed of evolving global regulatory requirements, standards,



and industry best practices.
- Assist in responding to requests from regulatory authorities and support regulatory correspondence where required.
- Ensure regulatory documentation is complete, accurate, and maintained according to company quality systems.

Required Qualifications

- Bachelor's degree in Life Sciences, Engineering, Chemistry, Biomedical Science, or a related technical discipline.
- Regulatory Affairs experience within the medical device industry.
- Experience preparing and coordinating regulatory submissions.
- Strong understanding of medical device regulatory frameworks and compliance requirements.
- Experience supporting regulatory audits and inspections.
- Excellent document management, organizational, and communication skills.
- Strong attention to detail with the ability to manage multiple priorities and deadlines.
- Proficiency in Microsoft Office and regulatory document management systems.

Preferred Skills

- Knowledge of FDA, EU MDR, TGA, or other global medical device regulations.
- Experience working in a regulated Quality Management System (ISO 13485 workplace preferred).
- Ability to work collaboratively in cross-functional teams.
- Strong analytical and problem-solving skills.

📌 Regulatory Affairs Specialist (Macquarie Park)
🏢 Lancesoft Australia
📍 Macquarie Park