Would you like to take part in transforming healthcare? Qbtech is the global market leader in professional ADHD tests, providing tests that are both CE marked and FDA cleared for use as an aid in the assessment and treatment evaluation of ADHD for people age 6-60. Our vision is to transform healthcare by providing a complete system of leading objective tests, products and services that empowers clinical and financial decision-makers to improve outcomes and support patients to better understand their symptoms and treatment.

Qbtech is present in 14 countries with offices in Stockholm, London and Houston. Over the next years, Qbtech will make significant investments into new products, technologies and people to further strengthen their services and product offerings with the aim of building an ecosystem with solutions for providers, clinicians and patients

Job Summary:

We are looking for a Quality Assurance Regulatory Affairs Manager to join our global QA/RA department to to support Quality Management System (QMS), update and implementation at Qbtech´s subsidiary in the United State.

The QARA Manager will act as US-agent Coordinator for Qbtech, with all tasks and responsibilities this role concerns.

Duties/Responsibilities:

• Perform facility and product registration in FDA´s database.
• Coordinate/ act as contact person for interactions with regulatory authorities (notified bodies included) and face to face meetings in Northern America; submission, reportable adverse events etc.
• Coordinate/ act as the host when the organization is subject for product clearance inspection or QMS audit.
• Have a great knowhow in Qbtech QMS, ISO13485 and Medical Device legislations, in order to provide support and advice to the organization.
• Perform internal and supplier audits.
• Secure document and record control.
• Coordinate quality processes and records; CAPA, Change Control, compliance and non-conformance handling.
• Perform training in QMS.
• Act as the deputy to Project Quality Regulatory Manager and/or System Quality Regulatory Manager at Qbtech head office.

Competency Required for Position:

• Knowledge of current revision of ISO13485:2016 and US 21 CFR Part 820.
• Knowledge of Premarket Notification and Premarket Approval processes.
• Knowledge of Medical Device Development.

Competency Desired for Position:

• Knowledge of current revision of ISO27001.
• Knowledge of U.S. Medical Device Regulations 510(k)

Qualifications Required for Position:

• Adequate scientific education. BSc or higher.
• Experienced from previous work with Quality Management in accordance with ISO 13485 and US 21 CFR Part 820.
• Experienced from previous work with Medical Device Development.
• High ability to interact with internal and external stakeholders.
• US citizen or having the US green card.
• Able to pass a background check.

Work Environment

• Hybrid working, with office located in Houston, Texas.
• Some domestic and international travel is required.
• Clean driving records.

What can Qbtech offer you?
At Qbtech you will have the opportunity to work with something meaningful that helps people understand ADHD while transforming healthcare. You will work in an international environment together with some of the leading experts in the world. You will lead the development of best in class as well as first in class products and services – globally. There are plenty of opportunities to learn and grow and to expand into other technologies within the company. Qbtech also offers education and certifications in fields that are relevant to the technology used within the company.