Healthcare Compliance and Regulatory Specialist

We are looking for a detail-oriented and knowledgeable Healthcare Compliance and Regulatory Specialist to support our compliance and regulatory efforts, especially within the Australian healthcare landscape. The ideal candidate will possess a deep understanding of Australian clinical trial processes, regulatory requirements, and healthcare systems such as NDIS and Medicare.

This role involves coordinating with international teams and ensuring that all practices adhere to high standards of compliance and documentation.

Key Responsibilities

Clinical Trial Support:

Assist in the coordination and management of clinical trials, ensuring they meet Australian regulatory standards.

Adapt trial practices to align with Australian healthcare frameworks and ensure compliance with local laws and regulations.

Regulatory Compliance:

Oversee and ensure regulatory compliance for healthcare products and services, with an emphasis on Australian requirements, specifically NDIS and Medicare.

Documentation and Reporting:

Prepare, review, and maintain critical documentation, reports, and submissions for clinical trials, regulatory bodies, and healthcare compliance audits.

Policy Liaison:

Act as the primary contact for Australian healthcare regulations, providing timely updates on compliance policies and regulatory changes to ensure best practices.

Cross-border Collaboration:

Work closely with Australian healthcare teams to facilitate communication and compliance across regions, ensuring regulatory alignment.

Key Qualifications

Experience in Clinical Trials:

Demonstrated familiarity with Australian clinical trial processes, compliance standards, and project management, including collaboration with international stakeholders.

Healthcare Regulatory Knowledge:

Strong knowledge of healthcare compliance and regulatory requirements, with a focus on the Australian healthcare system.

NDIS and Medicare Australia Expertise:

Well-versed in Australian healthcare systems, particularly NDIS (National Disability Insurance Scheme) and Medicare, with experience navigating regulatory frameworks.

Regulatory Documentation Skills:

Proficient in preparing, reviewing, and submitting regulatory documents that comply with Australian standards.

Attention to Policy Changes:

Ability to stay informed on policy updates, healthcare regulatory changes, and compliance requirements, both in Australia and globally.

Ideal Candidate Profile

Educational Background: Bachelor's degree in Nursing, Pharmacy, or a related field in healthcare or regulatory affairs.

Experience: 3-5 years in healthcare compliance, regulatory affairs, or clinical trials, with specific experience in Australian healthcare systems.

Skills: Strong communication, documentation, and project management skills, with meticulous attention to regulatory detail.

To Apply: Please send your resume and cover letter to [Confidential Information]