QA/RA Specialist
Raysearch Laboratories Ab (publ) / Kvalitetsbedömarjobb / Arvidsjaur
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hela Sverige RaySearch develops innovative software solutions to improve cancer care. About 1000 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe, Asia and Australia & New Zealand. Today we are more than 380 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination.
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.
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.
Your profile
To be successful in this role you work in a very structured and meticulous way. You have an interest in regulatory affairs and in explaining new software functionality, such as machine learning, to authorities. You adapt to changing conditions and have good communication skills. It is essential that you are well-organized but can be flexible when required. You recognize the importance of written processes and instructions and take initiatives to fill in any missing pieces. You can work independently and like to share your knowledge with colleagues.
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.
Application
Please apply to the position through the application form below. Selection and interviews will be ongoing.
Ersättning Enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2024-05-20
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Raysearch Laboratories AB (Publ) (org.nr 556322-6157)
Arbetsplats RaySearch Laboratories AB (publ)
Jobbnummer 8664336
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