Head of Quality and Regulatory Affairs

About

Bioliberty is on a mission to give everyone the best chance at recovery from a mobility-limiting condition or injury so they can regain their independence.

Founded in 2020, we've raised $17.5 million from a mix of public and private investors and launched our first product to the U.S. healthcare market in May 2025. We hold seven patents across our core technologies, Lifehub and Lifeglov - both of which are FDA-registered.

We’re now entering an exciting new phase of growth and are seeking an experienced Quality and Regulatory individual to join our team. Our team is diverse covering technical disciplines of hardware, software, embedded/fw, data and AI.

This is a unique opportunity to develop technology that makes a real-world impact, helping improve patient outcomes and enabling clinicians to deliver more effective and engaging therapy.

The role

As a senior QARA leader you will own and drive the company’s global Quality and Regulatory strategy. This role is central to shaping how we scale our medical device portfolio, ensuring that quality, safety, regulatory foresight, and data governance excellence are embedded into every strategic decision.

As a member of the Senior Leadership Team, you will act as the company’s authoritative voice on regulatory pathways, quality risk, cybersecurity, and compliance strategy. You will influence long-term product direction, market expansion, investment decisions, and organisational design. This is a role for someone who thrives in high growth environments and wants to build a world-class QARA function from the ground up.

Key Responsibilities

Executive Leadership & Strategic Influence

• Serve as a core strategic advisor to the c-suite and senior management, shaping the long-term roadmap, market entry strategy, and risk posture.
• Lead the development of a multi-year QARA strategy, ensuring alignment with commercial goals, product innovation, and global regulatory trends.

Quality Management System (QMS) Leadership

• Own and champion the company’s QMS, ensuring it is robust, scalable, adhered to and aligned with best-in-class medtech practices.
• Drive a culture of continuous improvement, operational excellence, and quality-first thinking across all functions.
• Lead audit strategy, management reviews, and long-term compliance planning.

Regulatory Affairs Strategy

• Lead regulatory strategy for all product lines, including submissions, technical documentation, and regulatory body engagement.
• Anticipate regulatory shifts and position the company to respond quickly and competitively.
• Build and maintain strong relationships with notified bodies, regulatory agencies, and external partners.

Risk, Cybersecurity & Data Governance

• Lead product and process risk management in line with ISO 14971.
• Ensure compliance with relevant standards, including IEC 62304, IEC 60601, and emerging AI/ML.
• Integrate cybersecurity and data privacy requirements into product development and organisational processes, supporting alignment with:
• ISO 27001
• HIPAA
• GDPR and UK Data Protection Act
• Provide executive-level guidance on data governance for connected devices and digital health platforms.

Organisational Leadership & Team Building

• Build, lead, and mentor a high performing QARA organisation as the company scales.
• Establish QARA as a strategic partner to Engineering, Clinical, Operations, and Commercial teams.
• Develop company wide training and capability building programs to elevate quality, regulatory, and data governance literacy.

Essential experience

• Significant experience in a senior QARA leadership role within medical devices, digital health, or similarly regulated sectors.
• Deep understanding of ISO 13485, EU MDR, UKCA, FDA 21 CFR Part 820, and harmonised standards.
• Demonstrated ability to influence executive teams and shape organisational strategy.
• Proven track record of leading regulatory submissions and managing complex regulatory interactions.
• Strong leadership, communication, and strategic thinking.
• Proficiency in eQMS software such as QuickVault

Desirable experience

• Experience with ISO 27001 & SOC2 implementation or oversight.
• Familiarity with HIPAA and PHI handling requirements.
• Strong grounding in GDPR, UK data protection law, and global privacy frameworks.
• Experience integrating cybersecurity into medical device development
• Exposure to AI/ML regulatory frameworks, algorithmic governance, or data driven medical technologies.
• Background in connected devices, cloud-based platforms, or digital health ecosystems.

Why Join Us?

• Shape the QARA function at a pivotal stage of growth and innovation.
• Hold a seat at the senior management table with real influence over company direction.
• Work on groundbreaking technologies that improve independence and quality of life.
• Join a mission driven, collaborative team

What we offer

• Competitive salary (depending on experience)
• Annual personal development budget
• 32 days paid leave (inclusive of public holidays)
• 3% employer pension contribution, 5% employee
• Private medical insurance covering optical, mental health, dental, and medical care
• Discounted gym memberships
• Flexible working arrangements
• A fully equipped tech setup
• Regular team get-togethers
• UK dedicated office based in central Edinburgh
• Cycle-to-work scheme for those working on-site
• Opportunities to travel for work to conferences, suppliers, customers and events
• To be part of a collaborative, passionate, and high performing team working to improve the lives of many

We are an Equal Opportunity Employer proud to foster a diverse and inclusive workplace.