Program Manager, Regulatory Affairs (Hybrid)

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Position Overview

Responsible for project planning and execution of cross-platform projects with regulatory impact. Plan and designate project resources, prepare budgets, monitor progress, and keep stakeholders informed. Job duties:
  • Represent Regulatory on project teams and partner with the cross functions on the team to ensure alignment of regulatory strategy with the team objectives.
  • Coordinate with Regulatory Affairs team to identify regulatory requirements for the markets identified in the regulatory strategy.
  • Research regulatory requirements and propose updates to internal procedures and practices to comply with requirements, as needed.
  • Determine and define project scope and objectives.
  • Predict resources needed to reach objectives and manage resources in an effective and efficient manner.
  • Prepare budget based on scope of work and resource requirements.
  • Track project costs in order to meet budget.
  • Develop and manage a detailed project schedule and work plan.
  • Provide project updates on a consistent basis to various stakeholders about strategy, adjustments, and progress.
  • Manage contracts with vendors and suppliers by assigning tasks and communicating expected deliverables, as needed.
  • Utilize industry best practices, techniques, and standards throughout entire project execution.
  • Monitor progress and make adjustments as needed.
  • Measure project performance to identify areas for improvement.
  • Perform additional responsibilities as assigned.

Job Details

    1. Minimum BA/BS degree or higher.
    2. Three (3) to five (5) years of professional regulatory experience.
    3. Five (5) to eight (8) years of direct experience as project manager in medical device industry.
    4. Ability to comprehend technical documents and concepts.
    5. Excellent verbal and written communication skills.
    6. Proficient computer skills (e.g., MS Office).
    Desired Qualifications
    1. Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
    2. Detail oriented.
    3. Experience in leading project teams, including project management certification.
    4. Ability to work well in a team environment.
    5. Proven analytical abilities and organization skills.
    6. Experience with US, EU, and ROW submission and requirements, 510k submissions, PMA Supplements, and Technical Documentation.