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?
An exciting opportunity has arisen for an experienced Quality & Regulatory Affairs Manager to join our team at Mawson Lakes. As a Medical Device manufacturer the Quality and Regulatory Affairs Manager is responsible and accountable for directing Quality and Regulatory activities to support all aspects of Ellex’s Quality and Regulatory programs. To maintain and improve systems, processes and initiatives that adds value to the overall
performance of the business through compliance with standards, regulatory requirements, and Quality Management System (QMS) arrangements.
Key Responsibilities/Accountabilities include:
Quality
- 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; take action as required to remedy any non-compliant areas;
- Report to Management on the performance of the Ellex Medical QMS; make recommendations that increases performance & compliance;
- Oversee and coordinate the Corrective Action & Preventative Action (CAPA) process and program, working with other departments to ensure timely issue resolution and CAPA closure;
- Provide suitable QMS training to team members and company employees; ensure records are maintained as appropriate;
- Coordinate, conduct and carry out internal quality audits and address noncompliance findings;
- Coordinate third party quality audits and address all non-compliance findings;
- Ensure quality assessment of all incoming parts, instruments, components, materials and manufacturing functions are completed effectively by applicable personnel;
- Oversee customer complaint & feedback records and adverse events reporting, including the investigation of such and liaising with the relevant depts. on those events which link with notified/regulatory bodies.
- Perform analysis of systems effectiveness and propose corrective and preventive actions as required;
- 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;
Regulatory
- In conjunction with the Regulatory Manager ensure Regulatory compliance in all nominated jurisdictions;
- Hold responsibility for Regulatory Compliance (act as “Person Responsible for Regulatory Compliance - PRRC);
- Drive change throughout the organisation through continuous improvement and, with the Regulatory Manager, is responsible and accountable for the development and submission of the Company’s TGA, FDA, CE and other regulatory filings;
- In conjunction with the regulatory team;
- support regulatory applications submitted by global distributors;
- take an active role in the review of proposed design development and change to identify possible Quality, Regulatory and Compliance implications.
- Maintain awareness of industry regulatory changes and impacts on Ellex with respect to Company products compliance and certification.
- Management of product & Regulatory risk management processes including risk analysis (risks), follow-up and traceability to product specifications;
- Manage any adverse events and/or recalls, including reporting and follow up.
- Participation in conduct and management of pre-clinical and clinical trials as required.
- Facilitate clinical evaluation reports, vigilance information for PMS and post market clinical follow up.
- Monitor applicable compliance requirements to ensure that:
- The latest versions are always available.
- Analysis of impact is conducted on new/changed requirements to identify and address potential risks.
General / Other
- Develop, manage and monitor budgets relevant to the Quality and Regulatory Affairs department;
- Ensure all administration activities are effectively managed and performed such as timesheets, training records etc;
- Other duties as requested that are in line with the functions and responsibility level of the role
Qualifications
- Qualifications in an Engineering related discipline and/or equivalent relevant experience.
- Lead Auditor Certificate held.
Demonstrated Skills/ Relevant Experience
- Exceptional skills in general business management principles and practices, including quality and risk management.
- High level skills in the coordination of an organisation wide Quality Management System; act as Management Representative.
- Sound ability in the interpretation and implementation of Medical Device Regulations [TGA, CE and FDA] and ISO13485.
- Leadership and Team Building.
- Relationships and Business Development.
- Exposure to and knowledge of Medical Device Regulations including FDA QSR 21 CFR part 820, MDSAP and ISO 13485.
- More than 5 years of experience at a Management level in a Quality and/or Regulatory role within a manufacturing company, ideally minimum of 3 years of these within Medical Device Manufacturing.
- At least 5 years professional experience in Regulatory Affairs, the application of Regulations and Standards to the Medical Device Industry or equivalent.
- Knowledge and experience in implementation of the requirements of the MDSAP program.
Why Ellex?
Ellex Medical has an inclusive and diverse workforce who champion the development of products that helps treat a range of eye diseases. Through their efforts, we have become a leader in the development of this technology. A true South Australian success story.
For additional information about Ellex and its products, please visit www.ellex.com
Only applications via Seek will be accepted.
Third party/agency applications are respectfully declined.
