SciBase, a global medtech company developing augmented-intelligence based products for skin cancer detection and eczema management is looking to recruit a QA/RA Manager. This is an excellent opportunity for applicants with drive, a thirst for hands-on responsibility a good understanding of EU and US medical device regulations and standards.
SciBase is based in Stockholm and sells world-wide with Germany and the US being key markets. The first product Nevisense is for the non-invasive detection of melanoma and non-melanoma skin cancer, and the company having added an additional indication recently under MDR continues to expand both its range of indications and products.
SciBase is one of the first companies in Sweden to be certified according to MDR and this is a chance to join a growing, innovative company working with unique, class IIa and III medical devices. SciBase has its headquarters in Sundbyberg, Stockholm and a production facility for their consumable electrode in Uppsala.
We will interview candidates continuously so don't wait to send in your application.
As our QA/RA Manager you will have responsibility for SciBase’s quality assurance and regulatory compliance. You will be responsible for hands-on management and implementation of systems and for developing the strategy for QA/RA. You will initially be supported by the current QA/RA Manager, with an aim for you assume full responsibilities as soon as it is practicable.
You will be a part of SciBase AB that today consists of 16 people and you will report directly to the CEO.
Responsibilities include but are not limited to:
-Maintaining and improving an already well-established MDR-compliant Quality management system according to ISO 13485 and FDA’ QSR and all other relevant standards
-Become the companies Person responsible for regulatory compliance (PRRC) as soon as practicable
-Production facility Support
-Management of day to day tasks such as Complaint management
-Communicating with regulatory authorities as well as with notified bodies
-Producing quality documentation and assuring conformity and regulatory compliance of technical documentation throughout the product’s life cycle
-Organisation of quality assurance and regulatory affairs training.
-Evaluating, managing and auditing key vendors
-Working with Consultants the clinical, product management, R&D and Production teams to plan and prepare regulatory filings.
-Responsible for conducting/coordinating internal and external audits.
-With the Product Management and Sales Teams, managing Post Market Surveillance
The right candidate has a university degree in a relevant field and a minimum of 3 years of documented experience within quality assurance, and preferably also regulatory affairs. You have experience working with medical devices under ISO 13485 + MDD/MDR and ideally also FDA regulatory frameworks. It is also a plus if you have worked closely with a medical device manufacturing unit either for devices or consumables or both.
An excellent command of English language, spoken and written, is an absolute requirement. Experience of working in a smaller, fast paced, and dynamic company is seen as an advantage for the role. You have a structured and organized way of working and can handle multiple tasks independently as well as manage priorities to meet project timelines. Furthermore, you are results- driven and enjoy working in broad role that includes a variety of tasks ranging from basic day-to- day operations to more strategic work.
To thrive in this role, you are reliable and eager to be a part of SciBase and take full responsibility. You have strong interpersonal and communication skills and a can-do attitude and also the will to go the extra mile to succeed.
Founded in 1998, SciBase AB is a Swedish medical technology company, headquartered in Stockholm, that has developed a unique point of care device for the accurate detection of malignant melanoma. The SciBase method is based on a technology called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. Nevisense is a point-of-care device that has emerged from more than 20 years of academic research at the Karolinska Institute.
SciBase sells mainly in the EU and the US and is the only approved product available for the detection of melanoma