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Regulatory Affairs Specialist

2 months ago

Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) Full time
About RaySearch Laboratories AB (publ)

RaySearch develops innovative software solutions to improve cancer care. With over 1000 clinics in more than 40 countries using our software, we strive to make the best cancer treatments available for patients worldwide.

About the Position

We are seeking a highly organized and detail-oriented Regulatory Affairs Support Specialist to join our QA/RA team of ten dedicated specialists and administrators. As a key member of our team, you will be responsible for regulatory vigilance and reporting to authorities.

Main Responsibilities:
  • Send and follow-up vigilance reports to regulatory authorities
  • Ensure high data quality in our customer database
  • Assist the QA/RA team with data management
  • Review and update records and documents
About You

We are looking for a proactive and flexible individual with excellent communication skills and a strong attention to detail. You should have experience in data structuring or document management, as well as database user skills and English at a high business level. Time management and ability to work in a structured and meticulous way are essential.

Requirements:
  • University degree
  • 2+ years' experience of data structuring or document management work tasks
  • Database user skills
  • English at a high business level
  • Time management and attention to detail
  • Ability to work in a very structured and meticulous way
  • Strong team working skills

It is an advantage, but not required, if you speak Swedish, have experience from submitting reports to authorities or similar, international business communication and working within a regulated area, especially with ISO 13485, QSR or MDR.