Apply your knowledge and skills to develop products that will have impact on millions of lives. Join our global company on this exciting journey
Due to continuous growth, an opportunity has arisen for a Regulatory Affairs Specialist to join us at an exciting time of launching new products. If you are motivated by innovation, like to work with diverse and brilliant people and you want an opportunity to play a part in changing the world, we’d love to hear from you.
Primary responsibilities for this role include:
Develop, adapt and implement Nanosonics global Regulatory strategies
Identify and manage Regulatory requirements applicable to our product submissions
Author and compile major Regulatory submissions for Nanosonics’ products and manage contact with corresponding Regulatory Authorities
Support and champion Regulatory activities necessary to bring and keep Nanosonics’ products on the markets including pre- and post-market activities
Provide guidance and training to Nanosonics’ employees in relations to Regulatory processes and obligations, mentor and support RA colleagues
Work with Senior Leadership to ensure adequacy, compliance, efficiency and improvement of the QMS processes related to Regulatory compliance, in Nanosonics product design, sourcing, manufacturing, distribution and service
Participate in cross-functional projects to ensure that Regulatory requirements are efficiently integrated in Nanosonics’ activities, I.e. major QMS update or new Regulations or Standards
Skills, knowledge and experience required:
Tertiary qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline
At least five years of professional experience in Regulatory Affairs or in quality management systems relating to medical devices
Understanding of risk management processes
Working knowledge of the requirements of ISO 13485 Quality Management Systems and FDA Quality System Regulations (QSR)
Experience as an Internal Auditor in Quality Management Systems would be a plus
High level documentation and systems management experience
High Attention to details is essential as well as ability to meet deadlines
Experience in project management would be a plus
Excellent communication skills to liaise with external customers and other function team members within the organisation
Able to work autonomously and to work within progressive and changing environment
Nanosonics Ltd is one of Australia’s most exciting companies. With a remit to develop novel technologies in the healthcare space, every day brings interesting and exciting challenges to our team. Our technology is now available in sixteen countries, with offices in Australia, North America, Canada, Europe and Japan.
We are already winning. Our first medical device, Trophon, reprocesses ultrasound probes to ensure that the risk of cross contamination is reduced, protecting more than 60,000 patients every day. Our Trophon technology has already been adopted by the top 50 luminary sites in the U.S, a 70% share of the market in Australia and is fast becoming the global standard of care. Not bad for an Australian company that’s only just getting started.
As Nanosonics continues to grow, our employees experience new and varied opportunities throughout the business. We now have almost 300 staff across Australia, North America, Europe and Japan. Joining the global team will see you working with colleagues who share the company’s “Infection Prevention. For Life” vision.