Regulatory Compliance Specialist
2 weeks ago
Job Overview: We are seeking a skilled Regulatory Compliance Specialist to join our Product Safety Team within the Compliance Management Branch in Medsafe. In this role, you will provide essential support to staff, health professionals, industry, and stakeholders to ensure effective regulation of medicines and medical devices.
Key Responsibilities:
- Process and maintain regulatory applications, ensuring compliance with Medsafe's policies and procedures.
- Manage and update databases (SMARTI, WAND, and Patengi/SharePoint), ensuring accurate record-keeping and accessibility of regulatory information.
- Handle invoicing, payments, and refunds, support process improvements, and contribute to Medsafe's Quality System and branch-wide projects.
- Provide advice to internal teams, industry, and stakeholders on regulatory requirements, section 29 processes, and GMP licensing.
- Support section 29 reporting, provide information for Official Information Act requests and media inquiries, and ensure Medsafe's compliance with health and safety obligations.
Requirements:
- A qualification or experience in a relevant field, e.g., Medicines or Health.
- A high degree of computer literacy and competence with the Microsoft suite of products.
- Strong prioritization skills, and the ability to work under pressure.
- Excellent communication skills, both written and oral.
- Experience working collegially in a team administrative environment.
- A strong drive for continual process improvement, embracing change, and finding efficiencies to enhance our regulatory operations.
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