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Regulatory Compliance Engineer

2 months ago

Cambridge, Cambridgeshire, United Kingdom CK Group Full time
Job Description

CK Group is seeking a highly skilled Quality Engineer to join their team in the Pharmaceutical industry. This contract role is based in Cambridge and will last for 12 months.

Key Responsibilities:
  • Design Control and Risk Management: Lead design control and risk management activities for combination product development programs.
  • External Collaboration: Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
  • Quality Compliance: Ensure combination product development activities are compliant with quality and regulatory standards.
  • Design Validation: Provide input and support to design validation, including human factors engineering assessments.
Requirements:
  • Education: BSc in an appropriate science and engineering discipline with previous experience in pharmaceutical combination product and/or device industries.
  • Regulatory Knowledge: History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
  • Design Controls: Experience in design controls and risk management for combination products.
  • Human Factors Engineering: Familiarity with Human Factors Engineering - Usability Engineering.
  • Manufacturing Processes: Familiarity with device assembling manufacturing processes.
About the Company:

Our client is a world-renowned innovative biopharmaceutical company, discovering, developing, and providing over 160 different medicines, vaccines, and consumer healthcare products to improve the lives of millions of people worldwide.

Working Arrangements:

This role is based at our client's site in Cambridge but offers hybrid working with 2/3 days a week on site.