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International RA Project Manager

Apply Now Job ID R-332920 Date posted 03/14/2019

Job Description Summary

Job Description

The International Regulatory Affairs Project Manager will lead development of key messaging, communication and development of artifacts including presentations for strategic programs supported by Regulatory Operations, such as the Bard Integration Operations Synergy Program, EU MDR/IVDR program, Brexit Impact, and Cost to Win programs.  

This position will also support the collection and analysis of programs with regulatory impact and communicate key data to the international regulatory team in order to allow the international teams to more efficiently and effectively conduct impact analysis and plan for support of the strategic programs. This person will be responsible for the development of the creation of stakeholder assessments, and development of communication plans for the appropriate venues. This position will need to take complex ideas and translate them into easy to understand information for all types of audiences.

The International Regulatory Affairs Project Manager will work with Corporate Regulatory Affairs, Corporate Regulatory Operations and International Regulatory Affairs program leaders to support change management through communications plans and execution.

This is an assignment position that will begin February 2019 and ends on or before September 2020 and does not offer relocation assistance.

  • Determine and discern detailed requirements on larger scale regulatory projects such as Cost Synergy Programs and EU MDR/IVDR to establish the project deliverables.
  • Partner with the EUDAMED team to build and maintain a database identifying SKUs impacted by changes, types of change, timelines for changes, and international impact across in scope strategic programs.
  • Build and maintain a database linking tech files to product families and SKUs for EU MDR/IVDR planning
  • Develop reports for International Regulatory that provide information allowing them to better plan for the resources required to support the in scope strategic programs.
  • Establish and maintain team members and project stakeholder relationships, expectations, and communications.
  • Monitor, track, and communicate progress of synergy-related international regulatory activities
  • Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify risks, perform required corrective actions, and communicate to all stakeholders up, down and sideways.
  • Execute and lead the completion of tasks as defined in the project management plan in order to achieve the project goals, and actively manages project risk.
  • Serve as a project management subject matter expert, keep Regulatory Affairs leadership abreast of project schedules and potential areas of conflict/concerns or delays.
  • Interface with senior management and support decision-making. Monitor timelines and developing strategies to stay on schedule and navigating through the internal regulatory and global program team governance for projects across business units, segments, and BDX.
  • Design surveys and perform data analytics
  • Internally, ensure that employees are aware of changes and projects within the company.
  • Distribute executive messages, prepare presentations and internal memos, and conduct meetings to share information.

Requirements:

  • B.S. degree or higher in a life science or technical discipline, preferably in biology, chemistry, engineering, bioengineering and regulatory affairs.
  • Project Management Certification (PMP) preferred and RAC is a plus
  • Minimum of 5 years of experience working in medical device industry is required
  • 3-5 years of regulatory affairs experience is required
  • Experience in large multi-national, multi business unit communications in healthcare industry
  • Broad international (outside of US, CAN and EU) RA experience in the healthcare industry (device, drug, IVD all acceptable)
  • Demonstrated proficiency in Microsoft PowerPoint, Microsoft Word, Microsoft Access, Power BI (or other reporting/visualization software) and Microsoft Excel.
  • Knowledge of quality systems and EU regulatory requirements
  • Previous working experience in a team oriented environment. Must have a team player mentality & ability to collaborate with multiple teams effectively

    Knowledge of Specific Procedures/Practices: FDA 21 CFR Part 820, ISO 13485, EU MDR/IVDR

  • Exceptional Communications Skills both written and verbal
  • Strong hands on PM skills for clear and timely follow through and documentation
  • EU MDR/IVDR understanding (plus)
  • Well-versed in program and project management tools and practices
  • Keen eye for quality and strong attention to detail
  • Written and spoken communication skills with excellent grammar, spelling, and clarity of thought. Documentation & mail will be seen by C Level executives and clients so all communication must be professional and well-written
  • Must be able to handle stressful situations with tact and confidence, as well as be able to operate under pressure and meet tight deadlines
  • Flexibility and ability to adapt and to work in a fast-paced environment with multiple deadlines
  • Must be able to work effectively across BD segments/units, regions, and manufacturing sites, and possess a high degree of integrity, good judgment, assertiveness, an approachable demeanor, and be able to elicit the respect and trust of BD associates.
  • Good organizational and planning skills, collaborative, team-oriented, possessing a positive attitude.
  • Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities.

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