Quality, Regulatory & Risk Manager

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

We’re 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 you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join us and be part of what’s next.

About the role

As our Quality, Regulatory and Risk Manager you will support the management and continuous improvement of Ada’s Quality Management System (QMS) to ensure compliance with global regulatory requirements, industry standards, and internal processes. You will play a key role in maintaining and enhancing quality assurance strategies, ensuring alignment with business objectives and regulatory requirements.

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

What you’ll do

• Develop, maintain, and improve quality management systems, SOPs, and technical documentation to ensure compliance with ISO 13485, MDR, and other applicable regulations.
• Provide technical writing support and act as subject matter expert (SME) for quality and regulatory documentation, processes, and procedures.
• Manage risk across medical device lifecycles, including risk assessments, failure mode analyses, mitigation strategies, and documentation to minimise potential harm.
• Review and assess nonconformance records, audit findings, and corrective/preventive actions to ensure timely resolution and regulatory compliance.
• Plan, prepare, and participate in internal and external audits and inspections, including supplier audits, ensuring readiness and adherence to quality and regulatory standards.
• Provide training and guidance to internal stakeholders on quality systems, regulatory compliance, risk management, and relevant standards.
• Support verification, validation, monitoring, and inspection activities for assigned product lines and processes, including production controls.
• Collaborate cross-functionally to assess, approve, and manage changes to products and processes in compliance with regulatory requirements.
• Drive continuous improvement initiatives in quality, risk management, and regulatory affairs to enhance efficiency, compliance, and patient safety.
• Serve as a proactive ambassador for quality and regulatory compliance across the organisation.

What you’ll bring

• Minimum of 2–3 years of experience in quality assurance and regulatory affairs, QMS operations, and regulatory compliance within the medical device software (SaMD) or health tech industry.
• Demonstrated experience in risk management across medical device lifecycles, including risk assessments, failure mode and effects analysis (FMEA), hazard analysis, and implementation of risk mitigation strategies.
• Knowledge of international and national regulations (e.g., Regulation (EU) 2017/745 (MDR), EU AI Act, MPDG), alongside working knowledge of ISO 13485, ISO 14971, IEC 62304, and IEC 82304.
• Strong working knowledge of quality management systems and relevant support tools (e.g., Jira, Github) to track and manage quality and risk-related processes.
• Ability to identify, assess, and mitigate risks associated with products, processes, and regulatory compliance, including cross-functional collaboration to implement corrective and preventive actions.
• Experience supporting audits, nonconformance investigations, and regulatory inspections with a focus on risk-based decision-making.
• Strong interpersonal, organisational, problem-solving, and analytical skills; strong attention to detail.

What’s 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 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.

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, 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 [email protected].

Please note that we do not accept 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.

*Any commercial activities concerning this advertisement will not be appreciated.