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RaySearch, a world leader in the field of advanced software for radiation therapy, is looking for a talented QA/RA Specialist 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 for a new member of the Quality and Regulatory Affairs team.
To be successful in this role you should be proactive and take initiatives that contribute to the goals of the department. You prioritize easily among a variety of tasks and enjoy working on several projects in parallel. It is essential that you are thorough, but when required you can be flexible and work fast without losing attention to detail. 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. In addition, you have strong team working skills and openly share your knowledge with colleagues.
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.
You will be responsible for:
- Filing product submissions and clearances for all markets
- Identifying market requirements and planning for new submissions
- Conducting complaint reviews for complaints related to patient safety
- Maintaining the work flow for Field Safety Corrective Actions
- Assisting our subsidiaries and distributors with regulatory questions
- Assisting with external audits and inspections
- Providing support and contributing to regulatory projects, processes and activities
Education & Experience
- University degree or equivalent in relevant area (e.g. engineering, science, law)
- Medical device regulatory work experience
- Experience with international business communication
- 3-5 years of medical device industry experience
- Experience from the software industry is a merit
- Knowledge of ISO 13485, QSR or MDD
- International product submissions
- English communication
- Excellent spoken & written English communication
- Document Management
- MS Office suite & database work items
- Understanding of international environment / companies
- Swedish communication
If you have a relevant university degree and work experience from ISO 13485, QSR or MDD and international product submissions, you are welcome to send your application as soon as possible. Please include your resume and a cover letter. Please click on the button below or by sending an email to email@example.com, mark the application “QA/RA Specialist, 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.