Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.
This role is offered as a 12-month contract, with the potential to transition into a permanent position based on performance and business needs. It presents an excellent opportunity for a dedicated professional to contribute to regulatory compliance and quality assurance, ensuring patient health and safety while collaborating with local and global stakeholders.
Your Mission: Submission projects for pre-market approval of products. Officer is required to ensure product conforms with legislative requirements; Prepare medical device submissions to the TGA and manage the technical file for these submissions in line with company processes; Liaise with local and overseas stakeholders to ensure all documentation is in place for new applications and existing certification; Facilitate the change notifications and global regulatory assessments; Maintain product registration data in ERP systems, inclusive quality control of data; Process product complaints and vigilance case. Tracking evaluation, communication & follow up ensuring all product/patient complaints are closed out with customers; Facilitate the quality element of product lifecycle management in Australia; Facilitate the management of ISO:9001 Quality Manual surveillance and certification process; with ISO 13485 future state. Maintain accurate and up-to-date documentation related to QMS; Collaborate with internal teams, provide training and guidance on quality assurance processes, standards, and compliance requirements; Conduct internal audits and follow up findings with investigations. Support key internal and external stakeholders with RA and QA requirements; Support ad hoc projects within the RA and QA department; Contribute to company intelligence in terms of regulatory or quality. Your Talent: A degree in biotechnology or an equivalent discipline; 3 years prior experience in regulatory affairs role in medical device industry, advantageous not essential; Experience with software such as SAP, CRM (e.g., Salesforce), Microsoft 365, Outlook, etc.; Effectively communicate across a broad audience including internal and external customers, regulatory bodies and industry associations; A collaborative approach, pleasant and approachable team player. Additional Benefits: Transport Allowance (if applicable to role); Onsite Parking; Accessibility to Public Transport; Flexible Work Arrangements; Wellness Programs and Activities; Professional Development Opportunities; Global Exposure & Business Travel Opportunities (if applicable to role). #J-18808-Ljbffr