- This medical device distributor has operated in Australia since the 1960’s.
- They have gained a reputation as the leading distributor of high-end medical products and services throughout Australia, currently representing over 200 product ranges from over 40 brands.
- They are proud to be powered by their people. They recognise the combined strengths and differences that every member of their team brings to the organisation.
- They aim to foster a work environment where people feel valued, productive and happy.
- They are powered by their people, and prioritise the professional growth of employees, recognising that their success translates to the success of the company.
- They encourage diversity and foster listening to the views of all.
- This Regulatory Affairs & Quality Manager position is to ensure continuous compliance and ongoing improvement in respect to Regulatory and Quality Systems.
- The role collaborates cross-functionally with internal and external stakeholders to ensure timely product registration and maintenance in accordance with Australian and New Zealand regulatory standards and management of quality system in accordance with ISO standards. A strong understanding of TGA, Med Safe, ISO/9001 and other international quality standards and regulations is needed for this job.
- Regulatory:
- Prepare and submit a range of registration and variation applications for required products with efficiency and independence. Interaction with the TGA, Medsafe, Department of Health and AICIS.
- Manage the timely application for permits, labelling changes and other regulatory documents.
- Timely execution of incident reporting, adverse event reporting and field actions.
- Review and approve advertising and promotional material to ensure regulatory compliance.
- Manage two direct reports, including assignment of RA/QA projects and task, training, and professional development.
- Create, maintain, and update the ARTG and WAND databases.
- Quality:
- Plan, lead, undertake and coordinate internal and external audits including audits by customers, business partners and external service providers. Conduct internal audits, as required.
- Manage document control and approval processes for all QA/RA related documentation including QMS related procedures.
- Ensure the maintenance, continual improvement and effectiveness of the Quality Management System (ISO 9001).
- Actively manage product complaints and non-conformances and lead investigations to establish root causes of issues by engaging with relevant teams.
- Work closely with the Pharmacovigilance service provider, sponsor and manufacturer in relation to licensing, registration and the collection and reporting of complaints.
- Prior experience, working with Class I, IIa, IIb and III medical devices and IVD's, working with the TGA.
- Degree in science related field.
- Minimum 5 years in regulatory/quality in the medical device industry.
- Resourceful, reliable, and able to work independently with excellent written and verbal skills in English, with 5 years minimum working in RA & QA in Australia.
- Experience in dealing with government agencies at all levels with a strong understanding of TGA, Medsafe, ISO and other international quality standards and regulations.
- Knowledge of Pharmacovigilance.