Clinical Governance and Regulation Lead 

• Company: This role will support all our businesses across Physitrack Group e.g. including Physitrack; Champion Health and Champion Health +
• Location: Remote, UK and Europe 
• Job Type: Fully Remote 
• Hours: Full-time, 40 hours per week.
• Base Salary: Between €50-60,000 per annum

We are seeking a dedicated Clinical Governance and Regulation Lead to join our Legal Team.

We are in search of a hungry and dynamic Clinical Governance and Regulation Lead. By joining our team, you will help Physitrack maintain high regulatory standards, while enabling all of Physitrack Group's teams to move at pace in a fast changing environment.

The world is changing rapidly with digitalisation and AI creating a unique opportunity to democratise healthcare. If you want to help us make the most of these opportunities, while maintaining high regulatory standards, we'd love to receive an application from you.

About Physitrack

At Physitrack our Mission is to elevate the world's wellbeing. We’re a global digital healthcare provider with team members of 14 nationalities on four continents, customers in 17 time zones, and millions of end users in 187 countries. Physitrack has two business lines:

Lifecare: Our Physitrack, PhysioTools and Physicourses brands. These provide digital tools for healthcare practitioners. 

Wellness: Our Champion Health, Champion Health plus, Champion Health Nordics and Wellnow brands. These provide holistic digital health for the workplace. 

This role is in our Legal Team, and will support both Wellness and Lifecare.

Responsibilities

As the Clinical Governance and Regulation Lead, you will be responsible for:

• Clinical governance: Overseeing and continually improving our clinical governance framework to ensure the utmost in patient safety and care quality. Including:
• Quality Management Systems: Oversee Quality Management Systems. You'll be comfortable performing a Management Representative role for QMS.
• International Organization for Standardization (ISOs): Oversee our approach to ISOs. 
• Product team collaboration: You will support the product team in creating and delivering healthcare innovations to the market.
• Regulatory Compliance: Ensuring all clinic operations comply with healthcare laws, standards, and regulations across the geographies that our businesses operate within. In due course, carefully consider any potential, or required, pathways to Medical Device status.
• Policy Development: Creating, evaluating, and updating policies and procedures in line with the latest clinical guidelines and regulations.
• Training and Development: Leading educational initiatives to keep our teams informed on best practices and regulatory requirements.
• Supporting all our businesses, including:
  • Physitrack
  • Champion Health
  • Champion Health +
  • Champion Health Nordics
  • Wellnow

Requirements

Qualifications: A degree in Physiotherapy, Healthcare Management, Public Health, or a related field with relevant experience in clinical governance and regulation and/or compliance roles. 

Experience: Proven track record in healthcare/ medical device compliance, clinical governance, or a related field within a healthcare setting. You'll have an understanding of medical device and related healthcare regulations and standards. In particular:

• Ideally you'll have worked for a global company and especially in the UK jurisdiction and medical space are ideal (MedTech and listed environments preferred); 
• You'll be familiar with how to perform in a compliance role with all the relevant regulations and laws that impact a UK HQ based global company.  
• Ideally you'll have successfully navigated regulations and the compliance function in various geographies, for example:

1. QMS up to ISO13485 certification; 
2. NHS DCB0129; 
3. Clinical Safety Assessment in the Design Control process;
4.  Medical device class 1 certification in UK and other parts of the world; 
5. HMRA; 
6. Data protection relevant regulations in particular UK, EU and US. 

Behaviours: 

• Dynamic and pragmatic: You'll be able to operate at pace, finding solutions which work for complex problems. You will look for opportunities to facilitate innovation and product development that enhances the customer experience while still adhering to relevant standards.
•  Business-minded: You will understand how process can both add, and damage, business outcomes.  
• Collaborative, self-aware and empathetic: You will understand all our teams and businesses in Physitrack Group and work closely with its people, in order to bring them on the journey with you. In particular you will have brilliant relationships with:
  • the Product Team, led by Patrycja;
  • Physitrack
  • Champion Health
  • Champion Health +
  • Champion Health Nordics
  • Wellnow

Hear from the hiring manager, Carla: 

"I'm looking for a dynamic and hungry individual to join our legal team. We're a friendly team that is spread across Europe.

We help all our teams to maintain high standards given the importance of, for example, customer data, while moving at pace to embrace the opportunities of digitalisation and AI. There is never a dull moment in the legal team!

If you want to work at an innovative company and help make a difference to people's wellbeing, I'd love to receive your CV".

Carla, 

Head of Legal and Investments (M&A) Strategy, Physitrack PLC

Benefits

• Fully remote and flexible working - see more here;
• We'll put your wellbeing first - see more here;
• 20 days Personal Time Off.

 How to apply

If you are excited by the prospect of maintaining high clinical and regulatory standards while ensuring Physitrack continues to innovate at pace, please submit your CV.

Physitrack is committed to fostering a diverse and inclusive environment. We welcome applications from candidates of any race, colour, religion, gender identity, sexual orientation, national origin, genetic information, disability, age, or veteran status.