Location: St. Paul, MN
Duration: 12+ months

Position Description:

  • Manages complex device projects within the B/U.
  • Assures the development of multi-level project planning to achieve short and long-term business objectives
  • Develops, tracks and reports on all key project deliverables.
  • Keeps senior management team informed of progress and issues.
  • Develops and communicates key performance indicators (cost/schedule/technical/quality) for projects.
  • Ensures project teams have appropriate resources to perform assigned tasks.
  • Interfaces with appropriate internal and external resources to ensure intellectual property is protected.
  • Reviews protocols and reports to support regulatory submissions.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications:

  • BA or BS degree (degree in a technical discipline highly preferred).
  • A minimum of 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
  • Ability to work in a highly matrixed and geographically-diverse business environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to travel up to approximately 15%.

Click to submit a resume or find additional support.