Regulatory/quality Officer
1 week ago
**Job Function**:Quality Management
**Location**:Macquarie Park, NSW, AU, 2113
**Work Flexibility**:Hybrid
**Job ID**:3924
- 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;
- 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
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