Zest Dental Solutions
2875 Loker Ave. East
Carlsbad, CA 92010
Sr. Regulatory Affairs MDR Specialist
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.
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.
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: email@example.com
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