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Sr. Regulatory Affairs MDR Specialist

November 12, 2019

 

 

 

 

 

Company Name:

Zest Dental Solutions

 

Job Location:

2875 Loker Ave. East

Carlsbad, CA 92010

 

Position Title: 

Sr. Regulatory Affairs MDR Specialist

 

Position Type:

Full-time 

 

General 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.

 

Responsibilities:

 

  • 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.

  • Manage the review cycles and any follow up meetings as needed.

  • Conduct lessons learned sessions to identify areas for improvement.

  • 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.

  • Tracks overview of all major submission and health authority activity to aid in Regulatory resource planning.

  • Other duties as assigned.

     

     

Qualifications:

 

  • 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 is required

  • Demonstrated experience in leading decision-making within cross-functional teams

  • Excellent organizational and communication skills, both written and verbal

  • Qualified project management experience; advanced expertise with project management related software and tools (i.e. MS Project, etc)

  • Basic understanding of FDA/EMA regulations and guidelines

  • Demonstrated ability to manage multiple projects is required

  • Ability to work independently as well as part of a team environment

  • Strong interpersonal skills, positive attitude, energetic and proactive

     

     

Application Information & Contact (How to Apply)

 

To apply, please email resume to: mark.stavro@zestdent.com

 

Learn more about Zest Dent here

 

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