Lead Quality and Regulatory Affairs Manager
We're looking for a Lead Quality and Regulatory Affairs Manager to join our team in Sydney, Australia.
Are you a skilled navigator of the quality and regulatory aspects of the medical device landscape? Are you passionate about building and implementing processes that enable people to do amazing things? Are you interested in applying your skills to what industry experts have called the most exciting QA RA role in Australia? If the answer is yes, then we would love to talk to you about this role!
We're Inventia Life Science and we are radically changing the way the world treats disease and injury. We're a multidisciplinary team, deeply inspired by the purpose of innovating for the better and backed by top-tier venture capital funds. We are now looking for a Lead Quality and Regulatory Affairs Manager to come on board and help us build out the quality and regulatory function of our business. This will support the development of Ligō - our platform to deliver cells and biomaterials to a patient’s wound site to achieve better healing outcomes.
This role provides an ideal environment for a forward-thinking, creative, and highly-motivated quality and regulatory expert to lead the development of Inventia's Quality Management System. You will play a key role in shaping the Inventia’s regulatory strategy. You will plan and implement the activities required to comply with local and international regulatory requirements, attain quality system certification, establishment registration and product registration. You will work closely with the product development teams to create and manage processes to ensure that records arising from the QMS and Product Technical Files meet regulatory, ISO and QMS requirements suitable to attain market clearances in designated countries.
The current team sits at just under 50. Our revolutionary 3D cell biology technology enables pioneers in the fields of drug discovery and medicine to radically drive innovation from disease treatment (in areas such as cancer) through to the way we treat injuries.
The role will report directly to the Head of Ligō and be responsible for leading the design and implementation of a QMS that will support the Ligō platform from design to market entry.
To be considered for this role we need someone with the following abilities to...
- Develop, implement and maintain QMS suitable for CE and ISO13485:2016 certification
- Obtain global regulatory approvals for medical products, including the representation of the
QA system during notified body audits
- Set up supplier audit and management processes in line with GLP and GMP, ensuring that
contracts and QA agreements are implemented and maintained
- Identify areas within a QA system for improvement, and represent those issues in discussions
with top management to drive improvements
- Learn quickly and proactively initiate action in a dynamic environment
- Clearly and concisely convey complex messages to an audience regardless of technical
background or level of experience
We highly value our culture, the diversity of the team and the passion we have for taking our product to market and the impact it will have. A lot of people talk about unique and exceptional cultures, but not many lead it. We place a high value on creating a unique and exceptional workplace.
Unlike many other startups, we live work-life balance. Our passions are many and we believe the journey is as important as the outcome. So for us, it's about building an exceptional team and culture and loving every part of what lays ahead. We provide optionality in terms of working from home and the office, which is based in Sydney. Equity and a strong market-based salary are on offer, within a supportive but empowered, fully agile environment, which we have worked hard to create.
Come and do work that really matters within a team that cares as much about one another as the mission.
If the above sounds like what you’ve been searching for, let’s start a conversation. We also strongly encourage you to apply even if you are not sure you fit all of the criteria we’ve mentioned. Come as you are - we believe that diversity drives innovation.
To express interest in this position please apply below! If you have any questions, please do not hesitate to email email@example.com