Head of Quality Assurance and Regulatory Affairs

About us

At Ada we envision a world where everyone gets the healthcare they need. Yet millions remain undiagnosed and untreated due to the complexity of identifying rare and underrecognized conditions even when effective treatments exist.

Were changing that. Powered by leading AI and built by a team of physicians and clinical scientists Ada helps people get answers faster identifying those at risk and guiding them to the right care. Every successful journey makes us smarter and able to help more people.

If youre passionate about transforming healthcare and ensuring no one goes undiagnosed join us and be part of whats next.

About the role

As our Head of Quality Assurance and Regulatory Affairs (QARA) you will be responsible for overseeing Adas Quality Management System (QMS) and regulatory strategy. You will be accountable for the maintenance and continuous improvement of our QMS ensuring alignment with Regulation (EU) 2017/745 (MDR) and other relevant regulatory requirements while supporting the companys business objectives. Additionally you will act as the primary point of contact for regulatory authorities managing interactions and submissions as needed.

Providing strategic regulatory guidance you will be responsible for ensuring that processes are efficient well-documented and meet compliance standards. Additionally you will also act as the companys PRRC (Person Responsible for Regulatory Compliance) under EU MDR (Article 15).

This is a remote role open to candidates based in the UK or Germany.

What youll 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 working directly alongside stakeholders and building a lean high-performance culture that adapts as Adas 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 companys 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.

What youll bring

• 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.

Whats awaiting you at Ada

• 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 lifes 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.

At Ada inclusivity isnt just a goal its our foundation.

As a proud equal opportunity employer we embrace diversity in all its forms. We encourage applications from every corner of society regardless of race color religion sex pregnancy status national origin age physical and mental abilities marital status sexual orientation gender identity gender expression genetic information and any other characteristic protected by law.

Join us in shaping a more inclusive tomorrow.

Contact

If you have any questions please feel free to contact us at.

Please note that we donotaccept applications sent via email. All applications need to be completed using the online form.

All your information will be kept confidential according to GDPR guidelines.

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