At a Glance
- Tasks: Lead the global Quality and Regulatory strategy for innovative medical devices.
- Company: Join Bioliberty, a mission-driven tech company transforming patient recovery.
- Benefits: Competitive salary, 32 days leave, private health insurance, and flexible working.
- Other info: Be part of a diverse team dedicated to improving lives through innovation.
- Why this job: Shape the future of healthcare technology and make a real-world impact.
- Qualifications: Extensive experience in QARA within medical devices and strong leadership skills.
The predicted salary is between 80000 - 100000 € per year.
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 involves owning and driving the company’s global Quality and Regulatory strategy, 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- 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.
- 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.
- 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.
- 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.
- Provide executive‑level guidance on data governance for connected devices and digital health platforms.
- 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.
Significant experience in a senior QARA leadership role within medical devices, digital health, or similarly regulated sectors is required. A deep understanding of ISO 13485, EU MDR, UKCA, FDA 21 CFR Part 820, and harmonised standards is essential. The candidate should have a demonstrated ability to influence executive teams and shape organisational strategy, along with a proven track record of leading regulatory submissions and managing complex regulatory interactions. Strong leadership, communication, and strategic thinking skills are necessary, as well as proficiency in eQMS software such as QuickVault.
Experience with ISO 27001 & SOC2 implementation or oversight, familiarity with HIPAA and PHI handling requirements, and a strong grounding in GDPR, UK data protection law, and global privacy frameworks are also important. Additionally, experience integrating cybersecurity into medical device development and exposure to AI/ML regulatory frameworks, algorithmic governance, or data driven medical technologies is beneficial.
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).
- 32 days paid leave (inclusive of public holidays).
- 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 Quality and Regulatory Affairs 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 benefits including 32 days of paid leave, private medical insurance, and flexible working arrangements, employees are empowered to make a real-world impact while enjoying a collaborative and inclusive work environment in the heart of Edinburgh.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Quality and Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with potential colleagues 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 the company and its products. Understand their mission and how your skills can contribute to their goals. This will help you stand out as someone who genuinely cares about their work.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Head of Quality and Regulatory Affairs. Highlight your leadership skills and any relevant achievements that showcase your ability to drive quality and compliance.
✨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 serious about joining our mission to improve patient outcomes and make a real-world impact.
We think you need these skills to ace Head of Quality and Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Head of Quality and Regulatory Affairs role. Highlight your relevant experience in QARA, especially in medical devices and regulatory compliance. We want to see how your background aligns with our mission at Bioliberty!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about improving patient outcomes and how your skills can help us achieve our goals. Be genuine and let your personality come through – we love authenticity!
Showcase Your Leadership Skills:As a senior leader, we’re looking for someone who can influence and inspire. In your application, share examples of how you've built and led teams, shaped strategies, and driven quality initiatives. We want to know how you can contribute to our growth!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at Bioliberty!
How to prepare for a job interview at Bioliberty
✨Know Your Regulations Inside Out
As a candidate for the Head of Quality and Regulatory Affairs, it's crucial to have a deep understanding of relevant regulations like ISO 13485, FDA 21 CFR Part 820, and EU MDR. Brush up on these standards and be ready to discuss how you've applied them in previous roles.
✨Showcase Your Strategic Thinking
This role requires someone who can influence executive teams and shape organisational strategy. Prepare examples of how you've developed and implemented successful QARA strategies in high-growth environments, and be ready to discuss the impact of your decisions on product timelines and market entry.
✨Demonstrate Leadership Skills
You'll need to build and mentor a high-performing QARA team. Think about your leadership style and prepare to share specific instances where you've successfully led teams, fostered collaboration, and driven a culture of continuous improvement.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Be ready to discuss how you would handle regulatory shifts or compliance challenges, particularly in relation to cybersecurity and data governance, as these are key areas for the role.
