
Regulatory Affairs Compliance Officer
2 weeks ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with internal and external regulatory requirements.
Main Responsibilities:
- Manage product compliance with internal and external regulatory requirements in Australia.
- Ensure compliance with regulatory requirements, including licence renewals, registrations, variations, notifications, reports, and submissions to regulatory authorities.
- Prepare, collate, and compile documentation.
- Respond to regulatory affairs issues and customer inquiries.
Key Requirements:
- Familiarity with Therapeutic Goods Administration (TGA) standards and regulations.
- Basic knowledge of ISO 13485 standards.
- Strong organizational skills and ability to perform complex tasks in a highly organized environment.
- Previous international experience in a similar RA function within the Healthcare sector.
- Strong understanding of local regulations and ability to exercise judgment regarding regulatory requirements.
- Strong interpersonal skills for influencing and negotiating with key stakeholders.
- Degree qualified in a relevant discipline.
Benefits:
This is an exciting opportunity for individuals who are passionate about regulatory affairs and compliance. If you have a strong understanding of regulatory requirements and excellent organizational skills, we would like to hear from you.
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