Global Regulatory Affairs Lead
7 days ago
Genea Biomedx is seeking a highly skilled Global Regulatory Affairs Lead to join our team in Sydney, Australia. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements, including those set by the Therapeutic Goods Administration (TGA).
Key Responsibilities:
- Develop, implement, and maintain global regulatory strategies to ensure compliance with regulatory requirements.
- Lead cross-functional teams to prepare, submit, and manage regulatory approvals for medical devices worldwide.
- Collaborate with regulatory agencies and manage inquiries related to submissions and compliance.
- Monitor regulatory changes and provide guidance on impact and implementation strategies.
- Support international product registrations, including FDA, CE Marking, and other global regulatory requirements.
Requirements:
To be successful in this role, you will need:
- Bachelor's degree in Biomedical Engineering, Regulatory Affairs, or a related field.
- 5+ years of experience in regulatory affairs, preferably in the medical device industry.
- Strong understanding of TGA regulations, and medical device quality management systems.
- Experience with global regulatory strategies, regulatory submissions, and compliance documentation.
- Ability to interpret and apply regulatory requirements effectively.
- Excellent communication skills and ability to work in a cross-functional team.
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