KARL STORZ

Regulatory Affairs – Quality Assurance Coordinator

KARL STORZ

full-time

Posted on:

Location Type: Hybrid

Location: Macquarie Park • 🇦🇺 Australia

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Job Level

Mid-LevelSenior

Tech Stack

ERP

About the role

  • Submission projects for pre-market approval of products.
  • 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
quality assuranceregulatory complianceproject managementquality management systemsISO 9001ISO 13485technical file managementproduct lifecycle managementinternal auditsdata quality control
Soft skills
effective communicationcollaborationteam playerself-motivatedapproachabilityproblem-solvingstakeholder managementtraining and guidanceattention to detailadaptability
Certifications
Bachelor’s degree in biotechnologyISO 9001 certificationISO 13485 certification