Freelance Life Cycle Management Specialist

4 weken geleden


Leiden, Nederland Yacht Voltijd
Job Description

Yacht Life Sciences is seeking a highly skilled Engineer LCM to join our team at Johnson & Johnson /Mentor Medical BV in Leiden. As an Engineer LCM, you will be responsible for managing multiple projects and initiatives, ensuring compliance with GMP/ISO standards and product design changes.

Key Responsibilities:
  • Manage and execute projects of high-level complexity, ensuring safety, regulatory compliance, and business needs are met.
  • Provide technical support and coordination between component sourcing and suppliers for new material cut-in and old material phase-out.
  • Lead labelling design projects, working closely with global and local teams to ensure labels meet regulatory and marketing requirements.
  • Work with design teams to confirm manufacturing bill of material, coordinate BOM drawing, and cooperate with local engineering teams on BOM change and management.
  • Represent the Labelling COE to customer groups and functional business partners, responding to and/or escalating as appropriate within the labelling COE.
  • Responsible for Unique Device Identification (UDI) application and management, ensuring all product UDI complies with local regulatory requirements.
  • Overall management of design change projects, working closely with local and global teams to track project progress.
Requirements:
  • Bachelor or Master Degree in Engineering, Biochemistry, Pharmacy, Biotechnology, Science, Innovation, Engineering or equivalent.
  • A minimum of 6-8 years' work experience in engineering and/or package labelling in a medical device environment preferred.
  • Fluent and excellent English reading, listening, writing, and speaking.
  • Experience in collaboration within a team environment across multiple time zones.
  • Experience in LCM (lifecycle management) or NPI (new product introduction) or product development.


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