Regulation and Quality Lead at Physitrack PLC Full Time

• Company: This role will support all of 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 seek a dedicated Regulation and Quality (in particular, Quality Management Systems) Lead to join our Legal Team.

We are searching for a hungry and dynamic individual who will help Physitrack maintain high regulatory standards, and by joining our team will assist in facilitating 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 QMS and Regulation Lead, you will be responsible for:

• Clinical governance: Working with our Clinical Safety Officer and product team to continually improve our clinical governance safety framework to ensure patient safety and care quality is always at the forefront of our thinking.
• Quality Management Systems: Oversee our Quality Management Systems. You’ll be comfortable performing a Management Representative role for our QMS.
• International Organization for Standardization (ISOs): Oversee our approach to our ISO13485-aligned Quality Management System, and current and future Medical Device Regulatory requirements.
• Product team collaboration: You will support the product team in delivering ISO13485 outputs, and facilitate them in creating, and delivering, healthcare innovations to the market.
• Regulatory Compliance: Ensuring that our operations, and products, comply with healthcare laws, standards, and regulations across the geographies that our businesses operate within.
• Policy Development: Creating, evaluating, and updating policies and procedures, following the latest 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: An ISO13485 Internal Auditor or Lead Auditor qualification would be advantageous as would a healthcare-related degree.  However,  experience in the implementation, and management of ISO13485-based Quality Management Systems,  and would also be just as acceptable.

Experience: Proven track record in overseeing medical device compliance, clinical governance, or a related field within a healthcare setting. You will have a good understanding of the regulatory environment of both medical devices and clinical safety.  In particular:

• Ideally, you’ll have worked as an ISO13485 QMS Management Representative for a MedTech company, and especially in the UK jurisdiction. 
• 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 will be aware of and have successfully navigated regulations and the associated compliance functions in various geographies, such as:
  • ISO9001;
  • ISO13485;
  • NHS DCB0129/160 Risk Management;
  • Medical Device class 1 certification, in the UK and other global markets;
  • EU MDR

Behaviours:

• Dynamic and pragmatic: You’ll be able to operate at pace, finding solutions for complex problems. You will look for opportunities to facilitate innovation and product development that enhance the customer experience while providing support to internal teams to ensure the organisation is adhering to relevant standards.
•  Business-minded: You will understand how processes can enhance business outcomes, while being mindful of the fast-paced environment, and therefore ensuring that the regulatory compliance function does not become overly bureaucratic.
• 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.