Location: Houston, TX
Reports to: Head of Quality Regulatory
Job type: Full-Time
Work Environment: An office based position with flexibility to work from home (3-4 days in office)
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. Qbtech is making significant investments into new products, technologies and people to further strengthen our services and product offerings with the aim of building an ecosystem with solutions for providers, clinicians and patients.
We are looking for a Quality Assurance Regulatory Affairs Manager to join our global QA/RA department to keep the Quality Management System (QMS) updated and in compliance with relevant legislation(s), and to ensure correct implementation of the QMS at Qbtech´s subsidiary in the United State. We will need this person to support Qbtech to fulfil the regulatory requirements when medical devices are intended to be
designed, developed, manufactured and distributed to the target market(s).
The QARA Manager will act as US-agent Coordinator for Qbtech, with all tasks and responsibilities this role concerns.
- 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.
- When applicable, as a member of the Product Development Team ensure compliance to Medical Device legislations and Qbtech QMS requirements when design and developing medical devices.
- Perform internal and supplier audits.
- Secure document and record control.
- Coordinate quality processes and records; CAPA, Change Control, complaint and non-conformance handling.
- Perform training in QMS.
- Act as the deputy to PQR Manager and/or SQR Manager at Qbtech head office.
Authorities for Position:
- Authorized to perform QMS document version updates.
- Authorized to perform internal audits.
- Authorities related to supervision of third-party suppliers.
- Authorized for interactions with regulatory authorities (notified bodies included) and face to face meetings.
Competency Required for Position:
- Knowledge of US healthcare regulations and Regulation (EU) 2017/745.
- Knowledge of US 21 CFR Part 820 and ISO 13485:2016.
- Knowledge of Premarket Notification and Premarket Approval processes
- Knowledge of Medical Device Development.
- Communication skills.
- Scientific skills.
- Ability for sustained accuracy.
- High ability to interact with internal and external stakeholders.
Competency desired for Position
- Knowledge of ISO27001:2013
- Knowledge in development of Software as Medical Devices
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.
- Verbal and written English proficiency.
- Able to pass a background check.
- Some domestic and international travel is required.
- Clean driving records.
What can Qbtech offer you?
Qbtech was founded in 2002, today we are over 80 employees working from Sweden, Netherlands, UK and USA with customers in all parts of the world. We are on a growth path and looking to double the team in 18 months. If you are passionate about transforming health care and work on great technology products, then don’t hesitate to apply!