Regulatory/Quality Officer (m/f/d)

Macquarie Park, NSW, AU, 2113

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 (eg salesforce), Microsoft 365, outlook, etc,
• Effectively communicate across a broad audience including internal and external customers, Regulatory bodies and industry association,
• A collaborative approach, pleasant and approachable team player.

Your Benefits

• Leave Benefits (Vacation 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