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Sr. Regulatory Affairs MDR Specialist

Company Name: Zest Dental Solutions
Location: 2875 Loker Avenue East, Carlsbad, CA 92010
Job Type: full-time
Contact Name: Mark Stavro
Phone: 760-743-7744, ext. 342
Fax: N/A
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: 

Job Description:

 

The Sr. Regulatory Affairs MDR (Medical Device Regulation) Specialist, is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.  This newly created role will be responsible for project management activities with a primary focus on the MDR regulatory project.  

Job Requirements: 

  • Responsible for project management of the cross functional EU MDR project team.  
  • Responsible for project management of the cross functional Standards team to ensure the new or revised Standards are assessed for impact on ZDS products, and managing team actions to completion.
  • Responsible for partnering with cross functional project teams, as needed, to ensure timelines and strategies are developed and effectively executed upon.
  • Develop and actively manages and monitors project timelines to ensure timelines remain on schedule.
  • Work with each function in detail to understand the individual deliverables and interdependencies between deliverables, in order to create and maintain an overall project plan timeline.
  • Identify and communicate both regulatory and project risks, with potential solutions to cross-functional project team and leadership as needed.
  • Prepare meeting agendas, meeting minutes and document decisions, action items and effective issue and risk mitigation plans. 
  • Create and distribute detailed project schedules, plans, timelines and trackers to communicate updates and project status.
  • Prepare monthly project reports, communicate and present project status to global project team and senior management.
  • Standardize process to view/manage overall, cross-portfolio Regulatory submission workload and view dashboard of submission status.

Education, Experience, Skills, & Abilities:

  • Bachelor’s degree in life-sciences or related scientific discipline; advanced degree preferred; PMP certification is a plus
  • 10+ years medical device or pharmaceutical industry and substantial experience working within Regulatory Affairs with an understanding of medical device development
  • Prior project management experience with medical device projects; expertise with project management related software and tools (i.e. MS Project, etc)