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Senior Regulatory Affairs Specialisti Pharm Consulting
BENEFITS Exciting growth opportunity in a newly created role Hybrid WFH policy and competitive salary package Small team of 4 reporting directly to the Regulatory manager RESPONSIBILITIES Planning, organising, leading post-market surveillance and global vigilance activities including adverse event reporting, co-ordination of field actions, and complaint evaluation. Ensure Customer Complaint Handling, Vigilance and Medical Device Reporting is completed in accordance with regulatory requirements Make safety and reporting decisions for routine matters. Collaborate with management and medical affairs for non-routine or serious events.
Identify and assess new or updated regulations for impact on the business, develop plans to implement these changes in the business, get stakeholder and management buy-in to implement regulations that have a significant impact on the business Work with global colleagues in support product registrations and submissions resulting from product changes. Serve as regulatory affairs representative for change management initiatives impacting on-market products and create and document regulatory strategies. Product change reporting/compliance assessments, review and approval of labelling, advertising and promotional material Participate in external audits including FDA and TGA REQUIREMENTS 3-5 years regulatory experience in Medical Devices is essential, diagnostics experience is beneficial Experience with new product submissions to TGA, FDA and EU regulatory bodies Confident in relationship building skills and stakeholder engagement Strong Attention to detail.