Regulatory Affairs / Quality Assurance Coordinator

Your Mission

• Submission projects for pre-market approval of products. This activity will expect candidate 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;
• 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 to 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 Talents

• Bachelor’s degree in biotechnology or an equivalent discipline preferred;
• 3 years+ prior experience in quality assurance, or regulatory role in medical device industry, advantageous not essential;
• Experience with quality management systems (ISO 9001 & ISO 13485)
• Project management skills, with proven success in achieving targets and committing to deadlines;
• Effectively communicate across a broad audience including internal and external customers, Regulatory bodies, and industry associations.
• Cross functional experience with softwares such as ERP, CRM, Microsoft ,outlook
• A collaborative approach, pleasant and approachable. Team player;
• Self-motivated when focusing on administrative tasks

Your Benefits

• Leave Benefits (Annual Leave, Sick Leave, Parental Leave, etc.)
• Birthday 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)
• All other statutory benefits