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European Union Medical Device Regulation Lead

Job Description

Alchemy are currently partnering with a global technology firm who are looking to recruit a European Union Medical Device Regulation Lead to be based onsite in San Diego, CA.

Core Skills:

  • Must have excellent communication skills(verbal, written, presentation & articulation), appropriate for varying levels of stakeholders.
  • Strong project management background in R&D or manufacturing environment
  • Experience in leading and managing a small group of engineers and technicians
  • Experience in working in offshore onsite environment
  • Demonstrated ability to effectively, critical thinking and clearly communicate concepts, ideas, and knowledge to other individuals and teams.
  • Desirable experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes.
  • Proficient in Microsoft Office products with an emphasis on MS projects, Excel and Word.

Responsibilities:

  • Manages and coordinates the STeD remediation for EUMDR requirements
  • Coordinates with cross functional team for their inputs to completes the STeD remediation
  • Conducts cross functional team review for STeD
  • Works with offshore team to address the gaps identified during the cross functional team review
  • Supports offshore in labelling remediation and co-ordinates CFT review for the new contents for labeling
  • Responsible for facilitating technical help to offshore team when required.
  • Responsible to have the STeD completed and made submission ready as per the timeline
  • Demonstrates excellent project management, contributes on projects as the R&D member, carrying out assigned responsibilities in a timely, diligent, safe and professional manner.
  • Develops and maintains good rapport with business leaders, other internal functions, technical consultants, outside vendors, and other stakeholders to accomplish project objectives and be a strong team-player.
  • Reviews the deliverables to ensure completeness, accuracy, and appropriateness of the design output/test executed and ensure its compliance with Good Documentation Practices.
  • Conducts Weekly Status Review Meeting with stakeholders, shares the progress of various projects supported/led, keeps a track on the self-utilization.