KARL STORZ

Regulatory Affairs & Quality Assurance Officer – AU

KARL STORZ

full-time

Posted on:

Location Type: Hybrid

Location: Macquarie Park • Australia

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Tech Stack

ERP

About the role

  • 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

Requirements

  • 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
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality assuranceregulatory complianceproject managementISO 9001ISO 13485medical device submissionstechnical file managementinternal auditsdata quality controlproduct lifecycle management
Soft Skills
effective communicationcollaborationteam playerself-motivatedapproachabilityproblem-solvingstakeholder managementtraining and guidanceadministrative focuscross-functional teamwork
Certifications
Bachelor’s degree in biotechnologyISO 9001 certificationISO 13485 certification