QARA Manager

Annalise in Chennai, India

As part of our RA / QA team you will have the unique opportunity to use your knowledge in regulatory and quality management systems and your passion for technology to bring to market cutting-edge AI-driven medical devices that positively impact patient lives at scale.

Why join us?
💜 Do work that matters. We’re pioneering AI software that will help diagnose medical images and raise the standard of healthcare for millions of people every day.
🌏 Well-funded and global. annalise.ai has a global presence across APAC, EU and US regions. We’re backed by I-MED radiology and harrison.ai (raised Australia’s largest Series B of $129m in 2021).
🌟 Work with a bunch of awesome, genuine people who are passionate about what they do.
🚀 Make an impact . You won’t be another ‘cog in the wheel’ here. We give full trust and autonomy for you to be heard, to work on the big hairy projects – and to make a real difference.
đŸŒ± Grow your career with us. We’re big believers in lifelong learning. You’ll be given a personal L&D budget, access to LinkedIn Learning, plus opportunities for internal mobility and leadership training to fast-track your career.
🌈 Do your best work and have fun doing it with monthly meditations, inclusive team events, and lots more!

About your role

As Quality Assurance and Regulatory Affairs (QARA) Manager at Annalise India Centre (AIC), you will be the site quality leader acting as the Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC) at AIC to maintain a quality management system (QMS) to ensure compliance with relevant regulatory and quality requirements in relation to manufacture of software-as-medical-device (SaMD) products, as well as maintain compliance to internal policies and procedures. You will manage regulatory clearances/approvals for products developed at AIC and managing existing/new product registration for India. You will also have the opportunity to learn from a multi-disciplinary team that consists of domain experts in Machine learning/Artificial Intelligence, Clinical Research, Software Design & Development and Marketing.
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What we’re about
We're problem solvers, redefining what’s possible in medical imaging through AI Technology. Our mission is to raise the standard of healthcare for millions of patients every day.

Yes, we’re a technology company and yes, we’re leveraging the latest AI technologies, but people are at the heart of everything we do.

annalise.ai was formed in early 2020 through a unique partnership between harrison.ai and Australia's largest medical imaging service provider, I-MED Radiology Network. Since then, we’ve scaled rapidly to over 200 employees worldwide and we’re focused on creating AI solutions that help radiologists diagnose medical images.

Our first product, the world's most comprehensive AI clinical decision-support solution for chest x-rays, is already available to 1 in 4 radiologists in Australia and rolling out to hundreds more. This solution is capable of detecting 124 findings and was recently featured in peer-reviewed publication, Lancet Digital Health journal.

And we’re just getting started.

Help us shape the future of AI in medical imaging. And most importantly, help us make a real difference in people’s lives.

What’s next?
If you’re inspired by what we're up to, please apply now and we'll be in touch soon.

We are proud to be an Equal Opportunity Employer. Diversity’s not a buzzword here, it’s in our DNA. Diverse perspectives shape our culture and make our work better. That’s why we’re committed to building inclusive teams that represent a variety of backgrounds and skills. If you need any reasonable adjustments, accessibility assistance or would like to note which pronouns you use at any stage of our hiring process, just contact us at accommodations: people@annalise.ai. We look forward to hearing from you.
    • Maintain the Quality Management System in accordance with ISO13485 and IEC62304 and other relevant medical device standards in AIC
    • Establish and assess quality KPIs throughout the relevant functions in AIC
    • Overseeingkey QMS processes in AIC including but not limited to NCR, CAPA, Change Management, Document Management and Supplier Management
    • Facilitate internal & external audits and management reviews in AIC
    • Manage and support quality plans and quality projects in AIC
    • Provide guidance, advice and training to internal stakeholders on quality principles
    • Develop regulatory strategy and provide regulatory requirements input for products developed in AIC
    • Establish and maintain medical device technical files and design history files
    • Prepare and facilitate regulatory submissions for products developed in AIC
    • Support product changes and submissions required for products developed in AIC
    • Facilitate adverse event reporting and field actions for products developed in AIC
    • Review advertising/market material to ensure regulatory compliance for products developed in AIC
    • Work with a multi-disciplinary team (marketing, clinical, product, and engineering) to ensure quality and regulatory requirements are met
    • Organise and coordinate the activities of the AIC QARA team, provide mentoring and coaching to the AIC QARA team.
    • Proven experience in a similar role;
    • Engineering or Life Science Degree or equivalent
    • Prior experience in the establishment and maintenance of a QMS in accordance with ISO13485
    • Knowledge of medical device regulatory requirements in the EU, US, AU or equivalent jurisdictions
    • Prior experience with regulatory submissions and clearances for SaMD or AI products
    • Comfortable working in a dynamic and fast-paced work environment
    • Prior experience working in a software-as-medical or AI company.
    • Practical knowledge and experience in relation to IEC62304 requirements
    • Sound knowledge of the FDA Quality System regulation (QSR) or EU Medical Device Regulations (MDR) or Medical Device Single Audit Program (MDSAP)
    • Manage inspections and audits from notified bodies and regulators
    • Experience handling adverse event reporting and product field actions
    • Sound regulatory knowledge in multiple international jurisdictions (e.g. Japan, China)
    • Communicate effectively, drive execution, foster innovation, focus on the customer, collaborate with others, solve problems creatively and demonstrate high integrity
    • Excellent analytical and problem solving skills
    • Collaborate across functional groups
    • Apply risk-benefit analysis techniques
    • Present & explain complex information to a variety of audience effectively
    • Evaluate options and recommend viable solutions to management
    • Plan training and education for a variety of stakeholders
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