Ada Health GmbH is seeking a Head of Quality Assurance and Regulatory Affairs to oversee our Quality Management System and regulatory strategy. You will be accountable for maintaining and improving our QMS, ensuring alignment with Regulation (EU) 2017/745 (MDR) and other global requirements, while supporting the company’s business objectives as a key internal subject matter expert.
What You'll Do
- Lead the development and implementation of regulatory and quality assurance strategies, ensuring compliance with MDR, FDA, and other international medical device regulations.
- Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team, setting clear priorities and building a lean, high-performance culture.
- Act as an internal SME on regulatory requirements, industry trends, and compliance best practices.
- Proactively advise management on regulatory changes and implications for Ada.
- Partner with Engineering and Product to integrate regulatory checkpoints into agile workflows and automate QMS processes.
- Oversee internal and external audits, including Notified Body audits and regulatory inspections.
- Serve as the primary liaison with Competent Authorities and Notified Bodies, representing the company in all regulatory discussions.
- Oversee regulatory submissions, including Technical Documentation reviews, with a focus on Europe, the UK and USA.
- Act as the company’s PRRC (Person Responsible for Regulatory Compliance) under EU MDR (Article 15).
- Lead the global vigilance strategy, ensuring the identification, investigation and reporting of serious incidents and field safety corrective actions.
- Act as the Management Representative under ISO 13485, reporting to senior management on quality and regulatory compliance performance.
- Ensure the technical documentation and the EU declaration of conformity for medical devices are drawn up and kept up-to-date.
What We're Looking For
- At least four years of professional experience in regulatory affairs or quality management systems related to software as a medical device (SaMD).
- Demonstrated ability to design and scale a lean QMS appropriate for a Series B/C startup.
- Strong expertise in EU MDR and in-depth knowledge of EN ISO 13485 is essential.
- Ability to negotiate with regulatory agencies, senior management, and other key stakeholders.
- Familiarity with global regulatory requirements.
- Experience in risk management for medical devices (ISO 14971) and proven audit experience.
- People Management experience with a proven record of managing, developing, guiding and scaling lean high-performance teams.
- The ability to navigate ambiguity and drive solution-oriented discussions, proposing pragmatic, technically sound mitigations.
- An understanding of how software is built, deployed and monitored to effectively ensure its compliance.
Nice to Have
- Experience with US FDA in addition to knowledge of AI/ML regulation (e.g. EU AI Act, FDA guidance on AI/ML) would be highly advantageous.
- German language skills would be a bonus but are not essential.
Team & Environment
You will lead and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
Benefits & Compensation
- Flexible working hours to maintain a healthy work/life balance.
- 28 days holiday, plus bank holidays to unplug, rest and recharge for our UK employees (30 days plus public holidays in Germany).
- Corporate health insurance and pension scheme (UK).
- Support to set up your home office space, with the option for a co-working space subscription for our remote employees.
- Parental benefits (Plus Nursery Benefits for the UK).
- Employee Assistance Programs to help you look after your emotional wellbeing and deal with life’s challenges.
- Stay active and healthy with a discounted ClassPass membership (or Urban Sports Club membership for our employees in Germany).
- Bike Leasing Scheme (Germany).
- Online Academy for learning and development opportunities.
Work Mode
This role is remote, open to candidates based in the UK or Germany.
At Ada, inclusivity isn't just a goal – it's our foundation. As a proud equal opportunity employer, we embrace diversity in all its forms. We encourage applications from every corner of society.
