Regulatory Affairs Manager

9 hours ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
About Us

Karo Healthcare is a dynamic and growing company that empowers people to make intelligent health decisions. We own and sell over 80 brands across seven categories, including medical products, and have a presence in about 90 countries.

We are currently looking for a Regulatory Affairs Manager to join our team in Stockholm. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the quality and compliance of our products, working closely with suppliers, manufacturers, and internal stakeholders.

This role requires a strong understanding of regulatory requirements, including GDP and GMP, as well as excellent communication and project management skills. You will have the opportunity to work on exciting projects that have a direct impact on our customers and the industry.

Key Responsibilities:

  • Ensure compliance with global regulations, including 2001/83/EC
  • Evaluate and manage supplier relationships, including qualification, validation, and audit planning
  • Lead internal audits and participate in external audits as a subject matter expert
  • Approve and close deviations, change controls, and product quality reports
  • Manage and maintain quality records, including PQRs, specifications, and analytical methods
  • Act as a process owner for certain Global QA team processes

Requirements:

  • Bachelor's degree in a scientific or technical field, preferably Master's degree in Pharmacy, Medicine, Chemistry, or Chemical Engineering
  • At least 5 years of experience in the pharmaceutical or medical devices industry
  • Fluency in English is essential; Swedish is a plus
  • Strong alignment with Karo values: professionalism, honesty, accuracy, and integrity


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