Benefits • Work with a leading Healthcare company with a global presence • Collaborative environment with a supportive team in place • Hybrid Opportunity – Competitive salary package + bonus
About the Company Our client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across Medical Devices.
About the Opportunity As a Senior Regulatory Specialist, you will manage regulatory compliance for a diverse range of medical devices. Reporting to key stakeholders, you'll play a crucial role in ensuring our client's products meet regulatory standards, impacting the company's market presence positively. This role would suit a self-starter, someone who has experience working in Regulatory Affairs within medical devices, has a strong attention to detail and ability to build strong relationships cross functionally. This is a hybrid role with the flexibility to work from home.
Duties • Monitor and update the regulatory landscape, gathering intelligence, and maintaining the database. • Collaborate with Regulatory Affairs Specialists to review and approve advertising and promotional materials. • Support product releases by assisting in the preparation and submission of Product Release Authorization documentation. • Ensure post-approval commitments to regulatory authorities are planned, tracked, and delivered on schedule.. • Participate in various projects and improvement process, including CAPA projects. • Represent Regulatory operations in cross-functional interactions with other departments such as Supply Chain, Customer Support, Quality, and IT. • Collaborate with cross-functional teams to integrate and meet regulatory requirements within Quality Systems. • Participate in internal and external audits, providing regulatory expertise and follow-up support. • Engage in interactions with regulatory agencies on defined matters • Monitor and update regulatory databases.
Skills and Experience • Experience in Regulatory Affairs with working knowledge of medical devices legislation • Degree qualification in sciences to related discipline. • Strong multitasking and detail orientation • Strong communication skills • Proactive and able to work in a fast passed environment. • Strong attention to detail
Culture Our client fosters an inclusive and collaborative culture, where every team member's voice is valued. Teamwork is at the heart of their success.
How to Apply Click to apply or contact Gemma Staddon, Specialist Manager, at 02 8877 8776 for a confidential discussion.
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