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Sr. Regulatory Program Manager

Apply Now Job ID R-331645 Date posted 03/01/2019

Job Description Summary

The Sr. Regulatory Program Manager - euMDR is responsible for the leadership and execution of implementing European Union Medical Device Regulation within BD Medical – Medication Delivery Solutions

Job Description

  • Determine and discern detailed requirements on euMDR to establish the program strategy, deliverables, and manage the scope, schedule, risks and budget.  
  • Develop program plan and timeline, keep the updated and reflective of authorized project changes.
  • Core Team Leader of the program. Establish and maintain a cross-functional core team and program stakeholder relationships, expectations, and communications across all MDS Business Groups stakeholders
  • Also serve as a regulatory core team member in the Core Team, provide regulatory direction and solutions to the program, and serve as the point of the point of contact for extended regulatory team members.
  • Work closely with MDS internal and external stakeholders to determine the strategy of euMDR implementation and manage the execution of the program across MDS Business Groups.
  • Execute and lead the execution of tasks as defined in the program management plan in order to achieve the project goals, and actively manages program risk.
  • Manage a team of 3rd party contractors and assign works as determined by the program. Keep leadership abreast of program 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 MDS business groups, medical segment and BDX.

Carry out the above tasks with minimal supervision.

Qualifications:

B.S. degree or higher in a life science or technical discipline, preferably in biology, chemistry, engineering, bioengineering and regulatory affairs.

Project Management Certification is a plus

RAC is a plus

Minimum of 10 years of experience working in medical device industry or equivalent. Experienced in leading and working in cross-functional comparable size programs. 3-5 years of regulatory affairs experience or working closely with regulatory affairs, good understanding of EU medical device requirements. Well-versed in program and project management tools and practices. Good knowledge of quality systems  ISO 13485, 21CFR 820

Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives. Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities. Project Management skills, Attention to details and organized.

#LI-TECH

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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