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Job Post Details

Quality Assurance and Regulatory Affairs Manager
ZEISS Group
·
3.7
Macquarie Park NSW
Full-time

Job details

Pay information not provided
Employee assistance program, Transportation links, On-site parking
Full-time
Macquarie Park NSW

Full job description

  • Join a world-leading optical company
  • Be part of a global team to drive quality of innovative healthcare and research solutions
  • Full time permanent role (hybrid) based in Macquarie Park, NSW
ZEISS is an internationally renowned Optical and Opto-electronic business with a clear strategy and vision to further develop the Australian & New Zealand business. With a proud history built on 178 years of technical innovation and annual R&D investments exceeding 15% of revenue, ZEISS Australasia offers market leading products in the Microscopy, Medical Technology and Consumer Optics industries.
ZEISS’s products and services are essential for medical procedures in ophthalmology and neurosurgery. The products of Vision Care help correct eyesight and manage the progression of Myopia in children. Our research solutions help scientist better understand diseases and develop better drugs and treatments. Join an exciting and innovative organisation in a role that provides opportunities to develop and make a difference.
Currently, we have a great opportunity to join our team as Quality Assurance and Regulatory Affairs Manager, based in Macquarie Park, NSW. Reporting the Head of ZEISS ANZ, in this role you will be responsible for the management and maintenance of our local quality system and regulatory framework with the aim of: supporting business continuity; complying with local legislation and corporate policies and standards; improving the customer experience; and increasing the operational efficiency of the business.
What you’ll be doing:
  • Oversee implementation and adherence to the corporate Quality Management System.
  • Conduct internal audits and manage ISO certification.
  • Develop and improve processes to boost efficiency and customer satisfaction.
  • Manage CAPA processes, adverse event reporting, and quality documentation.
  • Facilitate staff training on policies and procedures.
  • Ensure compliance with ANZ regulations (TGA, MEDSAFE, ACMA, AICIS).
  • Manage product registrations and regulatory submissions for new products.
  • Liaise with authorities and ZEISS global teams to maintain compliance.
  • Provide regulatory input for tenders and product launches.
  • Monitor and report on registration status and regulatory costs.
  • Engage with Global Heads of Quality and Regulatory Management across the global ZEISS network
  • Act as Compliance Officer, ensuring adherence to ZEISS Code of Conduct.
  • Participate in risk management reporting and meet internal/external reporting requirements.
What you’ll need:
  • Tertiary qualifications in a relevant field.
  • 3+ years’ experience in QA/RA, ideally in medical devices.
  • Knowledge of TGA submissions and ISO standards.
  • Strong auditing and documentation skills.
  • Excellent communication and stakeholder engagement abilities.
  • Recognised Auditor qualification (desirable).
What’s great about working at ZEISS?
  • Hybrid working options available
  • Competitive salary and bonus scheme
  • Discounted lenses and other optical products
  • Employee Benefits Program with access to hundreds of everyday savings at over 9,000 locations
  • Employee Assistance Program (EAP)
  • New office location, close to public transport and onsite parking
  • Supportive, family friendly working environment
  • Foundation owned organisation
  • Work at ZEISS and leave your mark in this world. With us, you can push technological boundaries, shape markets and contribute to the advancement of society.
For your opportunity to be part of a diverse, supportive organisation with a great company culture, please apply now.
Your ZEISS Recruiting Team:
Kellie Grant
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