C. R. Bard, Inc.

Project Manager, MDR

Posted Date 2 months ago(12/20/2017 4:41 PM)
Industry / Category
Project Manager, MDR
Job ID
2017-10974
Career Level
experienced
Division
Bard Medical Division
Relocation
Yes
Location
US-GA-Covington

Overview

C.R. Bard is looking for a talented and experienced Project Manager for Medical Device Review (MDR) to support the Regulatory Affairs team at our Bard Medical Division headquarters located in Covington, Georgia.

Summary of Position with General Responsibilities

This position is responsible for directing the activities related to the execution of Medical Device Regulations (MDR) projects across all functions within Bard Medical Division. The position will be required to interface with all project stakeholders at BMD, including stakeholders at multiple sites (e.g. regulatory affairs, quality assurance, labeling, manufacturing, etc.), to develop the appropriate project plans and timelines and ensure the assembled teams can successfully execute the assigned projects.

Essential Job Functions

 

Act as the team leader for MDR Projects within BMD.

  • Work with BMD management to assign appropriate resources.
  • Responsible for team meetings (e.g. face-to-face, teleconference, and/or webinars) and generation of meeting minutes.
  • Responsible for design reviews as needed.

Responsible for communication of team objectives, charter, milestones and progress

  • Owner of Planview project status updates for Projects.
  • Preparation of BMD reports and presentations.

Develop and track project budgets.

  • Work with Finance to prepare project financial models, budget tracking spreadsheets and reports.

Develop, assist in developing, and/or execute protocols and evaluations of products affected by MDR as needed.

Partner in continuous improvement of systems and procedures associated with executing MDR projects.

  • Help to identify stakeholders.
  • Work with all stakeholders to build consensus on areas for improvement.
  • Author new or modified procedures to address opportunities for improvement.

Ensure compliance with Corporate and Division product development policies.

Travel based on project needs (e.g. to BMD facilities, conferences, etc).

Basic Qualifications

  • Demonstrated project management skills or certifications.
  • Knowledge of EU regulations and implementation.
  • Thorough knowledge and understanding of FDA and ISO medical device development regulations; especially as they pertain to design control and product development.
  • Ability to teach and educate others of these standards as they pertain to product development and design
  • Knowledge of project-based product development and ability to work as a project leader.
  • Proficient in the use of a personal computer and Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Project.
  • Strong interpersonal skills required in the areas of verbal and written communications (with ability to influence), customer focus, time management, professionalism, coaching, influencing, and team building.
  • Strong information management skills.
  • Strong listening and assessment skills.
  • Strong analytical thinking, questioning & problem-solving skills.
  • Excellent organizational and time management skills.
  • Ability to build and manage database systems for information handling and communication.

Education and/or Experience

  • Minimum undergraduate degree (BS) in a technical or business management area and a minimum three years experience in medical device or pharmaceutical industry.
  • Demonstrated success in product development is required.
  • Experience with project management systems (e.g. Microsoft Project) is highly desired.
  • Experience in Quality Assurance or Regulatory Affairs is desired. 

Physical Demands

Employee may be required to sit, bend, stoop, use keyboard, see, talk, hear, and walk and stand on concrete surface for extended periods.  May occasionally lift objects up to 25 lbs.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

 

 

 

 

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Work Environment

This individual generally will work in an office environment with moderate noise and traffic.

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