Quality, Regulatory & Risk Manager
Ada Health
full-time
Posted on:
Location Type: Remote
Location: Germany
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About the role
- 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.
Requirements
- 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.
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
quality management systemsrisk managementrisk assessmentsfailure mode and effects analysishazard analysisISO 13485ISO 14971IEC 62304IEC 82304regulatory compliance
Soft Skills
interpersonal skillsorganisational skillsproblem-solving skillsanalytical skillsattention to detail