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RaySearch, a world leader in the field of advanced software for radiation therapy, is looking for a talented QA/RA Assistant with a regulatory focus to join our Quality and Regulatory Affairs team. This is a full-time position based at RaySearch’s head office located in the heart of Stockholm.
At RaySearch you will be part of a successful and fast-growing company that makes significant contributions to advancing cancer care through innovative software solutions. RaySearch offers stimulating work with great opportunities for personal development. We have a highly educated staff and low staff turnover. The company offers a very attractive work environment, flexible working conditions, a competitive benefits package and the chance of working for a good cause.
The Quality and Regulatory Affairs department is central to the company’s business as it is responsible not only for product market clearances, but also for manufacturer certificates and the Quality Management Systems of our head office and international subsidiaries. To continue our global expansion, we are now looking to strengthen the Quality and Regulatory Affairs team.
To be successful in this role you should be thorough, but when required you can be flexible and work fast without losing attention to detail. You are organized, self-motivated and possess a willingness to lend a hand with a variety of tasks when needed. You enjoy searching for information and solving problems both independently and collaboratively.
You have excellent communication skills, listen actively to what others have to say and adapt your communication expertise to the situation.
The Quality and Regulatory Affairs team is responsible for ensuring that RaySearch meets all relevant requirements applicable for a medical device manufacturer. We handle external and internal audits, certifications and market clearances, maintain the Quality Management Systems of the head office and subsidiaries and work with our colleagues to maintain efficient work flows and processes.
As a part of the Quality and Regulatory Affairs team, you will be assisting with:
- Quality and regulatory projects, processes and activities
- Administrative document reviews
- Follow-up of quality tasks and actions and internal training records
- Support of our subsidiaries and distributors with quality and regulatory related questions
- External audits and inspections
Education & Experience
- University degree or equivalent
- Experience from work in a regulated environment or industry
- Experience with international business communication
- Experience from the medical device industry
- MS Office suite
- Document management
- Excellent spoken & written English communication
- Understanding of international environment / companies
- Swedish communication
If you have a university degree and work experience from administration, you are welcome to send your application including a resume and a cover letter as soon as possible. Please click on the button below or by sending an email to firstname.lastname@example.org, mark the application “QA/RA Assistant, Stockholm, Sweden” in the heading.
The selection and interviewing process will be ongoing, and we would like to see the position filled as soon as possible. For further information about the position please contact David Hedfors, Quality and Regulatory Affairs Director.