Lynne Kenison Email & Phone Number

Acton, Massachusetts, United States

Marlborough, Massachusetts, United States

Westford, Massachusetts, United States

Managed, created, and released compliant US and OUS labeling. Spearheaded creation of IFUs table of contents template for consistency in all hardware and software IFUs for Abbott Vascular division. Labeling compliance SME that provides direction on labeling and IFU creation/updates. Developed and implemented Labeling Test Method protocols and reports to validate the accuracy of production labels and IFUs against Labeling Requirements Specification document. Organized process improvement by: Holding cross functional meetings to review. Created, preformed, and presented Technical Reviews to stakeholders mapping labeling and risk document to IFUs.

Burlington, Massachusetts, United States

Managed and accountable for project labeling deliverables including the development of point-of-care labeling, and human factor study labeling. Led the clinical chemistry hazard labeling (creation of product sample, box, and shipper labeling) from company safety data sheets (SDS) that followed the classification of labeling and packaging (CLP) and GHS guidance for labeling of hazardous materials. Responsible for obtaining label quotes, purchase order requests in SAP, and procurement from external vendor.Strategized, developed, and implemented global labeling and symbol SOP following FDA, ISO, IVDR, CLP, and other regulatory compliance. Developed and suggested improvements on quick reference guides and product labeling for human factors testing and clinical studies to improve usability, promote better customer comprehension, and make product more user-friendly.

Marlborough, Massachusetts, United States

Created, reviewed, monitored US and OUS labeling for Interventional Breast Solutions & Skeletal Health Division labeling and previously labeling for the Global Surgical Solutions division. Key project contributor in strategizing, development and implementing harmonized labeling SOP following FDA and EU regulations to ensure that consistent symbols and translations can be implemented onto all labeling.Produced 40% of the revenue product labeling and project management of 14+ product lines in both new and sustaining products for US, International, OEM, packaging, and IFUs with varying deliverables and deadlines. Implemented updates on labels for compliance with 60601, 15223, MDD, MDR, UDI, GTIN, Reach, RoHS, etc.Chaired weekly cross-functional team meetings for multiple product lines with significant change efforts.Partnered with OEM to ensure labeling elements are correct. Involved in OEM change management file transfer from OEM to Hologic as the design owner.Added labeling elements into Bill of Material (BOM) structure, verifying variable information were printed (LOT, SN, Date, UDI, etc.) and labels positioned on end products correctly.

Marlborough, Massachusetts, United States

Divisional Labeling Site Lead liaison for Costa Rica products by project managing depletion of stock and implementation of the 60601 initiative. Divisional lead/team lead/project manager for Master Brand and MDD initiatives. Divisional site lead for 22.6% of Boston Scientifics’ new and sustaining product labeling for the Costa Rica manufacturing plant. Project Management of 180 new product and sustaining US, International, and OEM packaging, labels, and IFUs on 23 different product lines with varying deliverables and deadlines.Developed timelines, tracked updates of all documentation including the tracking 170+ CRs through to completion, inventory, and depletion of existing stock.

Pepperell, Massachusetts, United States

Managing communication, budget, timelines, and printed documentation for full color direct mailers, full color data sheets, and brochures.Art director for hardware photo shoots, technical manuals, web graphics and animation, computer and web-based training, hypertext documentation, icon design, splash screens, animated screen saver for trade shows, corporate image and brand, and logo design. Clients include: Data General Corp.; Clariion Corp.; Sybase Inc.; Compaq Computer Corp.; Kronos Inc.; Digital Equipment / Compaq Corp.; Interactive Performance Solutions; ETNUS Inc.; InterChange Conference; SkillSoft Corp.; Global Knowledge; University of Massachusetts Lowell; Aurora Systems; Brix Network; ISU Insurance of Massachusetts; Jones and Bartlett Publishers.