Job Title: Clinical Device Assurance Specialist
About the Role:
We are seeking a skilled Clinical Device Assurance Specialist to join our team. The ideal candidate will have experience in device development and manufacturing operations, as well as implementation of design controls and ISO/FDA requirements.
Key Responsibilities:
* Support and guide device development programs throughout the lifecycle
* Establish and maintain Design History Files for development programs
* Collaborate with affiliates and third parties to ensure compliance with program deliverables
* Assess and integrate acquired combination products and medical devices into the product portfolio
Requirements:
* Education: Degree/Masters in engineering or science/life science
* Industry: Medical Device or Pharmaceutical (with devices)
* Experience: 5-7 years at similar level or 5-10 years general experience in industry
* Direct experience in device development and manufacturing operations in a GMP environment
Benefits:
* Opportunity to work on challenging projects
* Collaborative team environment
* Professional growth and development opportunities