Regulatory Compliance Specialist

10 hours ago


Uppsala, Uppsala, Sweden Cytiva Sweden AB Full time

Job Summary

Cytiva Sweden AB is seeking a Regulatory Compliance Specialist to join our Custom Engineering department in Uppsala. The successful candidate will have a strong understanding of regulatory requirements and guidelines related to bioprocess products and will be responsible for ensuring compliance with these regulations.

The ideal candidate will have experience with product development, process validation, and regulatory compliance. You will work closely with cross-functional project teams to ensure that all customer requirements are captured and implemented into the product.

Key Responsibilities

  1. Read customer specifications and translate these into specifications and designs.
  2. Perform design reviews internally and externally together with the customer.
  3. Coordinate design activities between functions (Mechanical, Electrical and Automation design).
  4. Ensure regulatory compliance of your products.
  5. Act as a support function for Service, Manufacturing and Verification.

Requirements

  • MSc or BSc in Engineering, Physics or Biotechnology, or equivalent.
  • Several years of documented experience from working with product development or process development within a regulatory controlled industry or environment.
  • Fluency in English, both written and oral is a requirement. Fluency in Swedish is an advantage.


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