Regulatory Affairs Specialist
- 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: Take the lead on establishing and managing Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
- Ensure quality: Drive the continuous improvement and maintenance of our Quality Management System (QMS) to ensure compliance.
- Navigate emerging tech regulations: Act as a key resource on the EU AI Act, working with subject matter experts to interpret and implement AI governance obligations.
- 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 the guidance of the Head of Legal and Regulatory Affairs.
- 3-5 years of hands-on experience in regulatory affairs within the UK and EU markets, including medical devices and ideally covering data governance, privacy, and emerging technology regulations like the EU AI Act.
- A strong ambition and readiness to lead projects and make a significant impact in a high-growth environment.
- A strong working knowledge of EU MDR 2017/745 and UKCA marking requirements, with familiarity with the emerging EU AI Act being a significant plus.
- Direct experience compiling technical documentation and managing PMS/PMCF activities, with a solid understanding of relevant ISO standards.
- A proactive and detail-oriented mindset, with a commitment to quality and the ability to drive tasks to completion.
- Excellent communication and collaboration skills, enabling you to work effectively with internal teams and manage external partners.
- A Bachelor's degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline.
- A passion for quality and a relentless drive to improve healthcare. You're an investigative mind with strong analytical and problem-solving skills.
- Fluency in English is required and proficiency in at least one other major European language is a benefit.
- 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 data governance professionals, 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.
- Flexible hybrid working environment, with 3 days in the office.
- Additional paid day off for your birthday and wellness days
- 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!
- Help us reimagine primary care and change the face of healthcare in Australia and then around the world
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