Regulation & Quality Lead Physitrack Remote in Europe and the UK

Company: Physitrack Group

Location and working hours: Part-time, Contractor (Ideally 2 or 3 days a week)

Hours:Remote within the EU or from our London office if UK based

Salary: Competitive, based on experience, up to 75,000 EUR full time per annum

Physitrack's mission is to elevate the world's wellbeing with our groundbreaking digital healthcare and employee wellbeing tools. With customers in 187 countries and a diverse team in 14 nations, we are transforming health outcomes through technology, evidence, and a human centred approach.

We are looking for a Regulation and Quality Lead to join Physitrack on a part time contract basis. Your primary focus will be to prepare the organisation for MDR/UKCA certification.

This role is ideal for someone who enjoys bridging the gap between product, engineering, and compliance in a fast moving digital health environment.

You will work closely with our Product, Engineering, and Clinical teams across the full product lifecycle of the Physitrack and Champion Health platforms. Your mission will be to ensure that our Quality Management System (QMS), risk management, and compliance processes evolve as our products move towards medical device status under MDR and UKCA frameworks.

You will collaborate with internal stakeholders - including our Information Security and Legal teams - and manage relationships with external regulatory consultants. This is a hands on role for someone who is passionate about building quality into products, not just maintaining documentation.

The ideal candidate will have experience with Quality Management Systems (ISO 13485 / ISO 9001), Medical Device Software (SaMD), or Regulatory Compliance in a digital health or wellness environment. However, we are also open to hearing from candidates with deep experience in one of these areas and a strong product mindset and willingness to grow into the others.

Experience working with NHS Trusts, digital therapeutics, or software validation in healthcare is a strong plus.

• Bachelor's degree, preferably in a technical, scientific, or regulatory discipline.
• Proven experience working in healthcare, wellness, medtech, or a digital product company.
• Proven experience liaising with teams on challenging compliance areas
• Practical experience with one or more of the following:
  • Quality Management Systems (ISO 13485 / ISO 9001)
  • Medical Device compliance (MDR, UKCA, FDA 21 CFR Part 820)
  • Software lifecycle & validation (IEC 62304)
• Understanding of risk management (ISO 14971) and usability engineering (IEC 62366) is desirable.
• Fluency in using AI based tools for decision and workflow support, such as ChatGPT, Grok or Meta AI, as well as fluency in using document and AI powered presentation creation tools such as Canva and Gamma.
• Comfortable collaborating across disciplines - Product, Engineering, Clinical, and Legal.
• Skilled at engaging and influencing senior stakeholders.
• Excellent written and verbal communication skills.
• Pragmatic, detail oriented, and commercially aware.
• Proven experience liaising with teams on challenging compliance areas
• Experience with AI/ML enabled health products or digital therapeutics is an advantage.

• Maintain and continuously improve Physitrack's QMS and compliance frameworks.
• Lead internal quality and risk processes for product development.
• Collaborate with product teams to ensure features and releases align with MDR and ISO requirements.
• Manage external consultants working on medical device classification and certification.
• Partner with Information Security and Legal to align documentation and audit readiness.
• Prepare the organisation for MDR / UKCA certification and related audits.
• Educate and empower internal teams on quality best practices.

• Commitment to improving health and safety through better digital care
• Detail oriented and strategic thinker
• Builder mindset-hands on, proactive, evidence led
• Clear communicator and collaborator across teams and cultures
• Respect for diversity and inclusion-everyone is welcome at Physitrack

If you are excited to help shape compliance and quality in a rapidly growing digital health organisation, please submit your CV for review. Physitrack Group is an equal opportunity employer that values diversity. All employment decisions are made on qualifications, merit, and business need.