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Regulatory Project Manager_EUDAMED

Apply Now Job ID R-334847 Date posted 04/02/2019

Job Description Summary

The Project Manager is (RPM) is responsible for managing the activities and deliver the results required for meeting EUDAMED and eIFU requirements per EU MDR for four business groups under MDS by the EU deadline.

Job Description

RESPONSIBILITIES:

  • Create master project plan and strategy for MDS on how the data attributes will be collected and delivered to corporate information system for submitting to EUDAMED and making IFUs available on the BD website.
  • Identify resources and tools required to collect the data attributes in scope by the EU deadline.
  • Lead the execution of the activities in collecting, verifying, approving and maintaining the data attributes. Manage 3-party for contracted activities.
  • Become lead contact with EUDAMED/eIFU corporate team and sharing project status.
  • Collaborate with EUDAMED/eIFU business group teams as needed and provide oversight for project progress, status reports and timely completion.
  • Coordinate priorities with other EU MDR work streams to feed into the overall success of the EU MDR program.
  • Escalate issues quickly to ensure high quality project delivery.
  • Create project report outs on status, risks and issues.

QUALIFICATIONS:


EDUCATION:

B.S. degree in a life science or technical discipline

LICENSES OR CERTIFICATIONS:

Project Management Certification desirable but not required

EXPERIENCE:

  • 7-9 years of experience working in medical device industry or equivalent, proven track record of successful project management experience
  • Experience and knowledge with UDI, GUDID, eIFU highly valuable
  • Experience in working with multiple teams at different global sites and complex systems
  • Well-versed in program and project management tools and practices
  • Knowledge of quality systems and EU regulatory requirements including the MDD and MDR for medical devices is advantageous

SPECIAL SKILLS:

  • Excellent communication skills
  • Ability to drive the projects without authorities
  • Ability to rapidly build product knowledge and understanding of technical and scientific regulatory activities.
  • Project Management skills

KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:

  • FDA 21 CFR Part 820, ISO 13485

This position is through 9/30/2020. This position works closely with the RA Leadership Team, and our hope is the candidate would find a long-term position within BDX

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com