Regulatory Affairs / Quality Assurance Coordinator at KARL STORZ

Macquarie Park, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Assurance, Project Management, Communication, Quality Management Systems, ISO 9001, ISO 13485, Collaboration, Training, Internal Audits, Data Management, Product Lifecycle Management, Stakeholder Support, Complaint Processing, Technical Documentation, Problem Solving

Industry

Medical Device

Description

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

Responsibilities

The role involves managing submission projects for pre-market approval of medical devices and ensuring compliance with legislative requirements. It also includes maintaining product registration data and facilitating quality management processes.