Job Description

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

About Physitrack

--------------------


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.

About You

-------------


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.

Skills & Experience

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.

What You'll Do

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.
#

What We Value

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

How to Apply

----------------


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.