Heidi is on a mission to build the indispensable medical AI that humanity can’t live without. We believe that in 2050 every clinician will practice with AI systems that free them from administrative burden and increase the quality and accessibility of care to patients across the world. Today, we have a suite of tools that modernise the way patients receive and clinicians provide care. Heidi Scribe transcribes consultations to generate clinical notes, documents and next-step actions. These tools are being stitched into a platform that will define a new mode of providing healthcare.
We’ve recently raised our $10M Series A led by Australia's largest VC firm, Blackbird Ventures and we have an ambitious global go-to-market strategy starting with the US and Europe. Therefore we are growing our compliance team and are seeking a driven Compliance and Legal Associate to work on our Heidi product features, contributing to the development and advancement of the healthcare industry.
As the Compliance and Legal Associate, you'll be responsible for working across Heidi in cross-functional efforts to ensure our products adhere to the highest standards of regulatory compliance across multiple jurisdictions. You will help maintain regulatory dossiers, manage the Quality Management System, audit timelines, and maintain international compliance with data governance, security, and privacy requirements. The role involves drafting contracts, working with external legal consultants, and safeguarding the company's compliance with international frameworks, enabling us to build reliable products that meet market needs and regulatory demands.
What You'll Do:
Work in Cross-Functional Teams: Guide management and teams in achieving quality and regulatory objectives throughout product design and development lifecycle.
Regulatory Dossiers: Develop and maintain the necessary regulatory dossiers for license applications and monitor regulatory adherence through product and labelling changes.
Contract Drafting: Draft and review contracts with external stakeholders, including suppliers, clients, and partners. Ensure all agreements comply with relevant regulatory requirements and protect the company's interests.
Post-Market Surveillance: Ensure compliance with post-market surveillance obligations and regulatory reports. Organize and attend internal and external audits and overseeing the preparation of necessary documentation and corrective action plans
International Compliance: Monitor compliance with information security, data governance, risk management, and privacy regulations across Australia, New Zealand, the US, UK, and Canada.
Quality Management System: Maintain and update Quality Management Systems.
External Collaboration: Work with external legal and regulatory consulting agencies to ensure internal execution of their advice and guidance.
What We'll Look For:
Minimum of 2 years in legal work, regulatory affairs or compliance with experience or knowledge in frameworks like ISO, GDPR, HIPAA, TGA, and FDA.
Strong legal skills, particularly in drafting and reviewing contracts and agreements, as well as a solid understanding of corporate law.
Bachelor's degree in health sciences or law, or equivalent is preferred but not essential.
Familiarity with healthtech, software or consumer health solutions.
Proven ability to influence cross-functional teams.
Negotiation skills and international deal-making experience.
Keen eye for detail, excellent organizational skills, and the ability to manage multiple projects in a fast-paced environment
Comfortable with ambiguity and an extremely fast-paced startup environment with multiple competing priorities.
What do we believe in?
We create unconventional solutions to difficult problems and we build them fast. We want you to set impossible goals and make them happen, think landing a rocket but the medical version.
You'll be surrounded by a world-class team of engineers, medicos and designers to do your best work, inspired by our shared beliefs:
We will stop at nothing to improve patient care across the world.
We design user experiences for joy and ship them fast.
We make decisions in a flat hierarchy that prioritizes the truth over rank.
We provide the resources for people to succeed and give them the freedom to do it.
Why you will flourish with us 🚀?
Flexible work with a hybrid environment
Additional paid day off for your birthday and wellness days
Full gym access in our Melbourne location and Sydney TBC..
A generous personal development budget of $500 per annum
Learn from some of the best engineers and creatives, joining a diverse team
Become an owner, with shares (equity) in the company, if Heidi wins, we all win
The rare chance to create a global impact as you immerse yourself in one of Australia’s leading healthtech startups
If you have an impact quickly, the opportunity to fast track your startup career!
