The Labeling Manager has overall accountability for product labeling programs. The Labeling Manager will provide guidance to the Labeling team to develop and maintain product labels and instructions for use (IFU). This position will identify, initiate, and drive labeling projects to support and improve the labeling program. Job duties: Manages product labeling programs. Develops strategies for continuous improvement to the labeling program. Leads the labeling team to ensure all labeling changes comply with regulatory requirements and guidelines as well as company policies and procedures. Ensures appropriate testing is performed prior to implementation of changes. Provides strategic leadership on global labeling process improvement initiatives. Manages complex labeling projects for continuous improvement to support the ever-expanding MicroVention product portfolio and requirements specific to various global regions. Provides day-to-day direction to the Labeling team to ensure timely and accurate completion of labeling projects. Manages CAPAs and NCRs relating to labeling improvements. Identifies opportunities for procedural improvements and leads the Labeling team to complete such improvements in a timely manner. Accountable for the labeling database (SQL) procedures. Collaborates with cross functional labeling partners and guides the labeling team to ensure labeling requests are completed accurately and in a timely manner. Manages the FDA Global Unique Device Identification Database (GUDID) program for product labeling. Owner of the UDI database for FDA and other global agencies. Performs additional responsibilities as assigned.
Qualifications Bachelors degree in Engineering or other relevant discipline, or equivalent experience. Minimum five (5) or more years of experience in product labeling in medical device field. Minimum two (2) or more years of experience in management or in leading teams. Minimum two (2) or more years of experience in project management. Working knowledge of relevant standards, including 21 CFR 801 Labeling, 21 CFR 820 Device Labeling, 21 CFR 830 Unique Device Identification, FDA 89-4203, ISO 15223, and CDRH Guidance Document, GUDID. Desired Qualifications Knowledge of global regulations and guidelines pertaining to labeling. Demonstrated ability to understand implications of label changes on pending and approved labels. Successfully manage large projects with the ability to motivate cross-functional teams to complete their assigned tasks. Strong skills in team leadership and development. Strong skills in configuring new labels in CodeSoft and LabelView software. Strong ability to manage labeling databases. Ability to work effectively and confidently in a team environment. Ability to multi-task and prioritize projects to meet deadlines. Ability to present labeling strategies and obtain alignment from stakeholders (including upper management). Excellent written and verbal communication skills. Ability to write, review, and approve labeling procedures. Ability to translate regulation requirements into practical procedures. Demonstrated skills in project management. Proficient with MS Project, Word, Excel, Outlook, SolidWorks. PMP certification desired, but not required. Experience in Medical Device field.