Buscojobs | Regulatory/Quality Officer

Vor 6 Tagen

Central Coast, Österreich Tideri Jobbörse 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 the medical device industry, advantageous but 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).
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