MedTech Quality Assurance / Regulatory Affairs (QA/RA) specialist

Brainlink is looking for a Quality Assurance / Regulatory Affairs (QA/RA) specialist

About Brainlink

Brainlink AB is a Swedish medical technology startup sprung from the inside perspective of neurosurgery. Our core focus is to integrate today’s technology into existing treatments that globally affect more than a miilion patients yearly. We aim to create breakthrough medical devices for more effective diagnostics and treatment of neurological conditions, while saving resources for hospitals and healthcare staff worldwide.

Who are we looking for

We are looking for a Quality Assurance / Regulatory Affairs (QA/RA) specialist with a passion to transform healthcare through assisting in solving complex design problems. In this role you will work together with our team of engineers and management, taking on activities related to all areas of the product development cycle. You have excellent organizational and project management skills.

Background

As QA/RA specialist, you will participate in key cross functional activities in support of medical device development. In this role you are expected to be readily available and flexible to support a broad range of technical needs of the company.

In this role, your responsibilities will include:

● Developing and sustaining Brainlink's Quality Management System for Regulatory Compliance.

● Participate in activities related to ideation, valuation, testing and verification of product development.

● Work collaboratively with the engineering and management team.

● Communicate effectively within the team as well as with external touchpoints.

● Support in keeping the timeline of delegated internal and external tasks, report progress and status through weekly updates.

● Application of standards and standard operating procedures for the product development.

Required qualifications

● University degree (MSc or equivalent) in engineering or biomedicine.

● Minimum 2 years experience in QA / RA in medtech product development.

● Experience in medtech product development.

Recommended qualifications

● Experience in regulatory assurance for medical implants.

● Experience in medical technology development.

● Experience working with sensor systems and/or wireless signaling in a medical environment.

Brainlink offers you

● Use your experience to improve healthcare outcomes and make a real difference to patients around the world.

● Participate in creating a new paradigm within MedTech.

● The opportunity to work at arm’s length from clinical medicine.

● A work experience that is challenging and rewarding, with space for independent thinking, innovation, and growth.

Salary: To be discussed

Employment conditions: Full- or part time (minimum 50%)

Location: On site: Gothenburg, Sweden. Candidates preferably currently based in Gothenburg, but we do welcome applications from citizens located outside Sweden.

EU Visa is mandatory.

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