Ada Health

Head of Quality Assurance – Regulatory Affairs

Ada Health

full-time

Posted on:

Location Type: Remote

Location: Germany

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Job Level

Lead

Tech Stack

SDLC

About the role

  • 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, working directly alongside stakeholders, and building a lean, high-performance culture that adapts as Ada’s regulatory and quality needs evolve.
  • Act as an internal SME (Subject Matter Expert) on regulatory requirements, industry trends, and compliance best practices, as required.
  • Proactively advise management on regulatory changes and implications for Ada.
  • Embed and automate Compliance in the SDLC: Partner with Engineering and Product to integrate regulatory checkpoints into agile workflows and automate QMS processes to reduce friction and increase delivery velocity.
  • 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 to ensure compliance and strategic alignment.
  • 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 to the appropriate regulatory bodies (e.g., BfArM, FDA, MHRA).
  • Act as the Management Representative under ISO 13485, reporting to senior management on quality and regulatory compliance performance, including Management Reviews.
  • Ensure the technical documentation and the EU declaration of conformity for medical devices are drawn up and kept up-to-date.

Requirements

  • 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, with a track record of cutting waste, improving efficiency, and enabling the business to move quickly without compromising compliance.
  • Strong expertise in EU MDR and in-depth knowledge of EN ISO 13485 is essential.
  • 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.
  • 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 within a dynamic and collaborative environment.
  • The ability to navigate ambiguity and drive solution-oriented discussions, proposing pragmatic, technically sound mitigations that enable product progress while meeting regulatory and safety requirements without over-engineering or unnecessary delay.
  • An understanding of how software is built, deployed and monitored to effectively ensure its compliance i.e. you are comfortable discussing deployment pipelines, release automation and software testing frameworks.
  • German language skills would be a bonus but are not essential.
Benefits
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory affairsquality management systemsEU MDREN ISO 13485US FDAAI/ML regulationrisk managementISO 14971audit experiencesoftware compliance
Soft Skills
people managementnegotiationsolution-oriented discussionsability to navigate ambiguityteam developmentcollaborative environmentsetting prioritiescoachingbuilding high-performance cultureadvising management
Certifications
PRRC under EU MDRISO 13485 Management Representative