Regulatory Affairs Specialist

1 week ago

Sydney, New South Wales, Australia Heidi Health Full time
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

Referral programs and job alerts are offered to help you stay informed about opportunities.


#J-18808-Ljbffr

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our organization in delivering regulatory submissions on time.Key Responsibilities:Deliver regulatory submissions within required timeframes;Ensure databases and systems are accurate and current by drafting, updating, reviewing and...

  • Regulatory Affairs Specialist

    1 day ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000

    Job SummaryClinical professionals looking to develop their expertise in regulatory affairs will find this role a stimulating challenge. We seek a detail-oriented and highly motivated Regulatory Affairs Specialist to support our team.Key Responsibilities:Support the preparation and submission of regulatory documents.Maintain accurate records and provide...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to deliver regulatory submissions and maintain compliance.Deliver regulatory submissions on time;Ensure accurate company databases and systems by drafting, updating, reviewing and verifying entries;Maintain compliance with regulations and provide expert advice as...

  • Regulatory Affairs Specialist

    5 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $120,000

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for supporting regulatory affairs activities for assigned products in Australia and New Zealand.Main Responsibilities:Support Regulatory Activities: Ensure compliance with all relevant regulations while assisting in developing strategies...

  • Regulatory Affairs Specialist

    1 day ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000

    Job Opportunity: Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs Specialist to drive regulatory strategy and manage compliance in Australia and New Zealand.This role will involve monitoring legislative developments, providing advice and support to internal stakeholders on legal and regulatory matters, and operationalising regulatory...

  • Regulatory Affairs Specialist

    5 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $125,000

    Job Title: Regulatory Affairs Specialist">Sydney Based Role:">We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team in Sydney. As a key member of our Asia business, you will be responsible for managing the regional and compliance frameworks of multiple products.">Key Responsibilities:">Determining requirements (local,...

  • Regulatory Affairs Specialist

    2 days ago

    Sydney, New South Wales, Australia Medella Life Full time

    Location- Sydney- Contact name:- Ethan Keating- Job ref:- 827- Published:- about 2 hours ago**Job Title: Regulatory Affairs Specialist (12-month Contract)****Location: Hybrid - Sydney, Australia****Key Responsibilities**:- **Regulatory Compliance**:- Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time

    Job Opportunity: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring the smooth flow of regulatory affairs activities and supporting the registration of new medicines in Australia.Key responsibilities include:Deliver regulatory submissions...

  • Regulatory Affairs Specialist

    5 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000

    Job Title: Regulatory Affairs SpecialistThis position is ideal for a detail-oriented individual with a passion for regulatory affairs in the cosmetics industry.Key Responsibilities:Build and maintain a master database of products to ensure compliance with the Australia Industrial Chemical Introduction Scheme (AICIS).Collaborate with marketing, supply, and...

  • Regulatory Affairs Specialist

    3 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000

    Regulatory Affairs Specialist WantedJob Description:We are seeking an experienced Regulatory Professional to join our team in Australia. The successful candidate will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors.In this role, you will be responsible for ensuring appropriate licensing,...