Overview
Join to apply for the Regulatory Affairs Specialist role at Heidi Health. Heidi is a healthtech startup focused on delivering world-class care with AI-enabled solutions. The role involves navigating regulatory landscapes for medical devices to support patient care in the UK and Europe.
What you'll do
* Drive regulatory strategy: Develop and implement quality and regulatory strategies for product development and commercialisation in the UK and EU.
* Lead conformity planning: Manage the company's medical device readiness, taking a lead role in detailed MDR and UKCA conformity planning and execution.
* Be a regulatory champion: Provide proactive regulatory guidance to cross-functional teams (Product, Clinical, Marketing) throughout the product lifecycle.
* Oversee technical documentation: Manage the development, compilation, and maintenance of UK/EU technical files, coordinating with internal teams and stakeholders.
* Manage post-market activities: Lead Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
* Ensure quality: Drive continuous improvement and maintenance of the Quality Management System (QMS) to ensure compliance.
* Navigate emerging tech regulations: Act as a key resource on the EU AI Act, interpreting and implementing AI governance obligations with subject matter experts.
* Act as a key liaison: Manage day-to-day interactions with UK and EU Notified Bodies, Competent Authorities, and external regulatory consultants.
* Own regulatory submissions: Prepare and manage regulatory filings and applications, taking ownership of the submission process under guidance from the Head of Legal and Regulatory Affairs.
What we will look for
* 3-5 years of hands-on experience in regulatory affairs within the UK and EU markets, including medical devices and ideally data governance, privacy, and emerging technology regulations like the EU AI Act.
* A strong ambition and readiness to lead projects in a high-growth environment.
* Working knowledge of EU MDR 2017/745 and UKCA marking requirements, with familiarity with the EU AI Act as a plus.
* Direct experience compiling technical documentation and managing PMS/PMCF activities, with understanding of relevant ISO standards.
* Proactive, detail-oriented mindset with a commitment to quality and task completion.
* Excellent communication and collaboration skills to work with internal teams and external partners.
* Bachelor's degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline.
* A passion for quality and a proactive problem-solving mindset.
* Fluency in English is required; proficiency in at least one other major European language is a benefit.
Why you will flourish with us
* Flexible hybrid working environment, with 3 days in the office.
* Additional paid day off for your birthday and wellness days.
* Opportunity to learn from a diverse team of engineers and creatives.
* Equity in the company if Heidi succeeds.
* Chance to create a global impact as part of Australia's leading healthtech startup.
* Fast-track your startup career with meaningful impact.
* Help reimagine primary care and transform healthcare in Australia and globally.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Information Technology and General Business
Industries
* Software Development
* Hospitals and Health Care
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