Head of Compliance
Sokin
Regulatory Affairs Specialist
Heidi Health
full-time
Posted on:
Location: 🇦🇺 Australia
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Develop and implement quality and regulatory strategies for product development and commercialisation in the UK and EU
- Manage medical device readiness, leading detailed MDR and UKCA conformity planning and execution
- Provide proactive regulatory guidance to cross-functional teams (Product, Clinical, Marketing) throughout the product lifecycle
- Manage the development, compilation, and maintenance of UK/EU technical files, coordinating with internal teams and stakeholders
- Establish and manage Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities
- Drive continuous improvement and maintenance of the Quality Management System (QMS) to ensure compliance
- Act as a key resource on the EU AI Act and work with subject matter experts on AI governance obligations
- Manage day-to-day interactions with UK and EU Notified Bodies, Competent Authorities, and external regulatory consultants
- Prepare and manage regulatory filings and applications, owning the submission process under guidance of Head of Legal and Regulatory Affairs
Requirements
- 3-5 years of hands-on experience in regulatory affairs within the UK and EU markets, including medical devices
- Experience covering data governance, privacy, and emerging technology regulations like the EU AI Act (ideal)
- Strong working knowledge of EU MDR 2017/745 and UKCA marking requirements
- Direct experience compiling technical documentation and managing Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities
- Solid understanding of relevant ISO standards
- Strong ambition and readiness to lead projects in a high-growth environment
- Proactive, detail-oriented mindset with commitment to quality and ability to drive tasks to 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
- Fluency in English; proficiency in at least one other major European language is a benefit
- Applicants will be asked about Work Authorization Status and sponsorship needs in the application form
