UDI Supervisor

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Location
Plymouth, MN
Salary
$85,000 - $95,000
Job Type
Direct Hire
Date
Dec 07, 2017
Job ID
2548725
GR Identifier: $Medd, $NEER


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We are seeking a high caliber Supervisor to oversee the Unique Device Identification (UDI) team. This position oversees the preparation and submission of UDI data and drives critical business initiatives to ensure compliance.
 
Responsibilities
  • As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing the collection, approval, and submission of UDI data elements.
  • The Team Leader ensures that the labeling and UDI meet all medical, legal, and regulatory requirements for medical devices.
  • Interacts with cross-functional teams in the creation and execution of UDI deliverables.
  • Serves as UDI liaison throughout the product lifecycle.
  • Participates in or leads some of the following labeling or UDI activities relative to acquisitions, manufacturing transfers, system updates, regulation changes (e.g., MDR), CAPA, and rebranding.
  • Ensures timely approval of labels and/or UDI for marketed products.
  • Serves as Labeling or UDI representative to marketing, research teams, regulatory or other functional teams.
  • Advises functional teams on labeling and UDI impacts regarding manufacturing changes, technical labeling, appropriate regulations, and interpretations.
  • 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.
  • Provides mentoring and leadership to Regulatory Specialist I and II team members
  • Performs other related duties and responsibilities, on occasion, as assigned.
 Your experience(s), education and knowledge
  • 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 experience in a medical device industry preferred
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 20%, including internationally.
  • Ability to identify and solve problems and work independently with little oversight.