Regulatory/Quality Officer

vor 4 Wochen

Sydney, Österreich Karl Storz Se & Co. Kg Vollzeit

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

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