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Title

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Specialist in Regulatory Affairs

Description

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We are looking for a Specialist in Regulatory Affairs who will be responsible for ensuring that the company complies with applicable laws and regulations within its area of operation. The role involves working closely with various departments to interpret and implement regulatory requirements, as well as staying updated on changes in legislation. You will be a key person in preparing and submitting documentation to authorities, handling regulatory questions, and supporting product development with regulatory insights. It is important that you have a good understanding of regulatory processes and can communicate clearly with both internal and external stakeholders. The role requires accuracy, analytical skills, and the ability to work independently in a dynamic environment. You will also contribute to developing internal procedures and training colleagues on regulatory matters to ensure compliance and minimize risks for the company. If you are committed, solution-oriented, and have experience in regulatory affairs, this is an excellent opportunity for you to grow and contribute to the company's success.

Responsibilities

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  • Monitor and interpret regulatory requirements and legislation
  • Prepare and submit documentation to authorities
  • Collaborate with internal teams to ensure compliance
  • Provide advice on regulatory issues during product development
  • Develop and improve internal processes for regulatory compliance
  • Train employees on regulatory matters
  • Manage communication with regulatory authorities
  • Identify and minimize regulatory risks
  • Follow up and report changes in regulations
  • Participate in internal and external audits

Requirements

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  • Relevant university degree in law, science, or similar
  • Experience working with regulatory affairs
  • Good knowledge of applicable laws and regulations within the industry
  • Strong analytical and communication skills
  • Ability to work independently and in teams
  • Meticulous and structured working method
  • Fluent in Swedish and English, both spoken and written
  • Experience with authority contacts is a plus
  • Knowledge of document management systems
  • Flexibility and problem-solving skills

Potential interview questions

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  • What experience do you have with regulatory processes?
  • How do you stay updated on changes in legislation?
  • Can you give an example of how you handled a complex regulatory issue?
  • How do you ensure internal processes comply with regulatory requirements?
  • What tools or systems have you used for document management?
  • How do you handle communication with authorities?
  • Can you describe a situation where you trained colleagues on regulatory matters?
  • How do you prioritize tasks in a dynamic environment?
  • What challenges have you faced in regulatory affairs and how did you solve them?
  • How do you work to minimize regulatory risks?