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Regulatory Affairs Project Manager

Date: Dec 11, 2018

Location: Brussels, BE

Company: Terumo BCT, Inc.

Country:  Belgium 

 

Regulatory Affairs Project Manager

 

JOB SUMMARY

 

Working under broad supervision, manages parts of project lifecycle from initiation to close. Help define and assure execution of project management, scope and timing by preparing formal project documents for the execution of a project. Effectively collaborate with vendors, technical resources and stakeholders.

 

ESSENTIAL DUTIES

  • Executes project plans and revises as appropriate to meet project objectives.  .
  • Facilitates and coordinates  activities and tasks involving project scope and schedule.
  • Facilitates the definition of quality and risk, and manages the project accordingly.
  • Tracks status and metrics on the project delivery involving scope and schedule.  Assures supervision is informed.
  • Resolves and/or escalates project-related issues in a timely fashion.
  • Manages communications, expectations, and interactions with all departments and internal stakeholders incl

    Terumo Penpol.

  • Delivers informative, well-organized presentations on project status and selected project topics, leads and reports on these presentations.
  • Manages technical documentation remediation work across product portfolio, working alongside the remediation teams.

     

     

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelors degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered

PMP or equivalent certification is preferred

 

Experience

Minimum  3 years experience working in Regulatory Affairs or Quality Assurance.  Should have project management experience relative to planning, organization, tracking and facilitating teams.  

 

Skills

  • Minimum three years experience in medical device regulations is desired, specific EU medical device regulatory experience is a plus. 
  • Demonstrated ability to communicate effectively both verbally and and in writing
  • Knowledge and use of relevant PC software applications and skills to use them effectively
  • Able to work with various backgrounds and cultures
  • Pro-active and strategic thinker
  • Able to keep focus and comply with strict timelines
  • Ability to manage all or parts of project lifecycle, from initiation to close.
  • Has had responsibility for preparing formal project documents for the execution of a project.
  • Experienced with defining project requirements and scope.
  • Demonstrated effective use of the disciplines of project management practices to plan and manage projects.
  • Shown ability to effectively collaborate with vendors, technical resources and stakeholders.

     

     

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

 

TRAVEL

Travel required (up to 5% - 3 times/year)


 

Join Terumo BCT as we Unlock the potential of blood.

 

As we strive to make even safer, higher-quality transfusions available to more people, we can unlock the potential of blood and cell therapies. We can help our customers bring even more treatment options to patients through advanced blood therapies. We can support researchers in developing cellular therapies that may fundamentally improve health care. Terumo BCT is guided by our customers' needs, aspirations and ongoing drive to improve efficiency and patient outcomes.

 

Each associate has a positive impact on our future and the lives of the patients we ultimately serve.


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