At a Glance
- Tasks: Lead the global Quality and Regulatory strategy for innovative medical devices.
- Company: Bioliberty, a mission-driven tech company improving patient outcomes.
- Benefits: Competitive salary, generous leave, private medical insurance, and flexible working.
- Other info: Join a diverse team and enjoy excellent career growth opportunities.
- Why this job: Shape the future of healthcare technology and make a real-world impact.
- Qualifications: Senior QARA leadership experience in medical devices or digital health.
The predicted salary is between 80000 - 100000 € per year.
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.
- Provide executive level insight on regulatory pathways (specifically FDA focused) and their implications for product timelines, resourcing, and investment.
- Champion a proactive, forward-looking approach to compliance, including cybersecurity, data privacy, and AI/ML governance.
- 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.
Head of Regulatory Affairs & Quality Management in Edinburgh employer: Bioliberty
Bioliberty is an exceptional employer, offering a unique opportunity to shape the Quality and Regulatory Affairs function at a pivotal stage of growth. With a mission-driven culture, competitive salary, generous leave, and a commitment to employee development, our Edinburgh-based team thrives on collaboration and innovation, making a real-world impact in healthcare technology. Join us to work on groundbreaking solutions that enhance patient independence while enjoying flexible working arrangements and a supportive environment for personal and professional growth.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Regulatory Affairs & Quality Management in Edinburgh
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching Bioliberty and understanding their mission. Tailor your responses to show how your experience aligns with their goals, especially in regulatory affairs and quality management.
✨Tip Number 3
Practice your pitch! Be ready to explain how you can contribute to shaping the QARA function at Bioliberty. Highlight your leadership skills and experience in driving compliance and quality strategies.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our mission-driven team.
We think you need these skills to ace Head of Regulatory Affairs & Quality Management in Edinburgh
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Head of Regulatory Affairs & Quality Management role. Highlight your relevant experience in QARA, especially in medical devices, and show how you can contribute to our mission at Bioliberty.
Showcase Your Leadership Skills:We want to see your leadership style! Share examples of how you've built and led high-performing teams in the past. This is a senior role, so demonstrating your ability to influence and mentor others is key.
Be Clear on Compliance Knowledge:Since this role involves navigating complex regulatory landscapes, make sure to highlight your understanding of ISO standards, FDA regulations, and any other relevant compliance frameworks. We’re looking for someone who can hit the ground running!
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to keep track of your application and ensure it gets the attention it deserves. We can’t wait to hear from you!
How to prepare for a job interview at Bioliberty
✨Know Your Regulations
Make sure you brush up on the key regulations like ISO 13485, FDA 21 CFR Part 820, and EU MDR. Being able to discuss these confidently will show that you’re not just familiar with the standards but can also navigate them effectively in a strategic role.
✨Showcase Your Leadership Skills
Prepare examples of how you've built and led high-performing teams in previous roles. Highlight your experience in mentoring and developing talent, as this is crucial for the Head of Regulatory Affairs & Quality Management position.
✨Demonstrate Strategic Thinking
Be ready to discuss how you would shape the long-term QARA strategy for Bioliberty. Think about how you can align quality and regulatory goals with commercial objectives and product innovation, and be prepared to share your vision.
✨Engage with Real-World Impact
Express your passion for improving patient outcomes and how your work in regulatory affairs can contribute to this mission. Share any relevant experiences where your decisions positively impacted patient care or product safety.
