AddressWho are we?
ELLEX MEDICAL, a part of the global LUMIBIRD Group, is a high-tech global Ophthalmic medical device company with more than 30 years success. We design, manufacture and market a premium line of equipment that diagnose and treat a range of eye diseases. We are consistently recognised as a global leader in ophthalmic laser & ultrasound technology and our devices are in use by leading eye surgeons around the world.
What will you do?
As a Medical Device manufacturer this position is responsible and accountable for directing Quality and Regulatory activities to support all aspects of Ellex’s Quality and Regulatory programs. You will be a collaborator have strong influencing skills, with a growth and continuous improvement mindset; not adverse to challenging the ‘status quo’ when required.
To be successful in this role you will have experience and capability to:
- Be a valued member of the Australian Senior Leadership Team
- Lead, coach and inspire a team of highly experienced Quality and Regulatory professionals
- Influence, build and maintain internal and external Stakeholder relationships in all aspects of QMS and Regulatory Affairs, driving a culture of continuous improvement and compliance
- Ensure that Ellex is fully compliant with ISO 13485, FDA Quality System Regulation (QSR), Medical Devices Directive (MDD, CE Marking), Japan PMDA Regulations and the Canadian Medical Devices Regulations (CMDR) and other relevant standards
- Report to Management on the performance of the Ellex Medical QMS; make recommendations for improving business capability
- Act as Ellex Medical’s Quality Management Representative (QMR); includes relevant standards such as FDA QSR 21 CFR part 820 and ISO 13485 & Brazil Resolution RDC 16/2013;
- Hold responsibility for Regulatory Compliance (act as “Person Responsible for Regulatory Compliance - PRRC)
- Maintain awareness of industry regulatory changes and impacts on Ellex Medical with respect to Company products compliance and certification.
Qualifications & Experience
- Degree Qualified (Australian University or equivalent), and more than 5 years leading a team in a Quality and /or Regulatory Affairs environment
- Lead Auditor Certificate held (or willing to obtain)
Why Ellex?
We are an inclusive and diverse workforce championing the development of products that help treat a range of eye diseases. Through our efforts, we have become a leader in the development of this technology. We are a World leader with a strong R&D and manufacturing team in Mawson Lakes.
If you would like to be a part of a continually growing business, where you can add value, we would love to hear from you. There is no closing date, so please upload your application via the SEEK submit button asap, or for more information or to request a copy of the PD please send an email to **@ellex.com
Adelaide is Australia's most livable city:
For additional information about Ellex Medical and our products, please visit www.ellex.com or take a look at the video below.
Third party/agency applications are welcome, **@ellex.com
