
Quality Manager for Medical Devices
2 days ago
We are the global market leader in professional ADHD tests, providing CE marked and FDA cleared tests for use in assessing and treating ADHD in individuals aged 6-60.
Our vision is to empower clinical and financial decision-makers to improve outcomes by providing a complete system of objective tests, products, and services that support patients in understanding their symptoms and treatment options.
About the Role
The System Quality Regulatory Manager (SQR Manager) will be responsible for ensuring our Quality Management System (QMS) remains updated and compliant with relevant legislation, including ISO 13485, 21 CFR 820, and EU-MDR 2017/745.
- Coordinate and host inspections and audits from notified bodies and authorities.
- Provide expert advice on Qbtech Management Systems and regulatory requirements.
- Collaborate with the Product Development Team to ensure compliance with medical device legislations and Qbtech QMS requirements.
- Perform internal and supplier audits.
- Ensure document and record control.
- Oversee CAPA, Change Control, Complaints, and Non-Conformances.
- Develop and deliver training in quality and regulatory matters.
- Experience working with Medical Device Software Development.
- Adequate scientific education, BSc or higher.
- Previous experience with Quality Management in accordance with ISO 13485 and US 21 CFR Part 820.
- Verbal and written English proficiency.
- Ability to pass a background check.
We seek an individual with expertise in:
- Regulation (EU) 2017/745, US 21 CFR Part 820, and ISO 13485:2016.
- Medical Device Software Development.
- Effective communication and scientific skills.
- Attention to detail and ability to interact with stakeholders.
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