QA/RA Specialist

at  RaySearch Laboratories

Do you want to improve the care of cancer patients by introducing new software medical devices to Europe and other markets? Join RaySearch and our QA/RA team and contribute to make the best cancer treatments available for patients all over the world.

SKILLS AND EXPERIENCE:

• University degree or equivalent
• English at a high business level
• Chinese or Japanese at a high business level
• International business experience
• Working within a regulated area (medtech, law, government), 3-5 years’ experience
• Filing submissions to authorities
• Flexible
• Meticulous
• Structured
  It’s an advantage, but not required, if you speak Swedish, have experience from software industry and knowledge of ISO 13485, MDD/MDR and QSR.

ABOUT THE ROLE

As one of our QA/RA Specialists, you will join the team of nine dedicated coworkers. The role requires previous experience from regulatory submissions, and we would also like to see that you have experience from the Asian medical device regulations specifically.
The QA/RA team is central to the company’s business as it is responsible not only for product market clearances, but also for manufacturer certificates and the corporate Quality Management System.
This is a full-time position at RaySearch’s head office located in Stockholm. As QA/RA Specialist, you will report to the QA/RA Director and be involved in all areas of the department.

YOUR MAIN TASKS:

• File product submissions and obtain market clearances
• Identify market requirements and plan new submissions
• Assist our subsidiaries and distributors with regulatory questions
• Assist with internal audits, external audits and inspections
• Lead or contribute to regulatory projects and vigilance activities
• Contribute to regulatory data quality in our customer and product database
  The role is a great opportunity for you to contribute to the care of cancer patients by enabling new software innovations to be quickly and reliably introduced in markets worldwide. You will have contact with authorities, subsidiaries and distributors and work closely with an international team happy to share knowledge.