.2 days ago Be among the first 25 applicantsDirect message the job poster from BVI MedicalBVI is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.
With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.
Our team supports surgical teams in more than 115 countries worldwide, either directly or through our network of trusted distributors.
Our trusted brands include: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium Intraocular Lenses).PURPOSECreates and updates labeling documentation and product information for medical device products, in order to optimize patient safety and minimize product liability risk.
Works with regulatory/medical quality, and other internal functional areas and with external regulatory agencies to ensure timely regulatory and quality compliance, and to support business objectives as required.RESPONSIBILITIESProvide package, labeling, and graphic design support for new product development/initiatives as well as support commercial/on-market, sustaining products, regulatory submissions, and tenders.Provide partner-related changes, other routine document revisions, and administrative services in support of instrument and product labels, specifications, and training materials.Create, revise, and control customer labeling, with a primary focus on documentation control through all phases of the change control process or based on quality agreement.Support new label process development using label software such as Adobe Creative Cloud, SharePoint, Prisym, BarTender, Teklynx/CodeSoft, SalesForce, and IFS.Write and edit documents, specifications, Standard Operating Procedures (SOPs), labels (box, variables, etc.)
and technical documentation (IFUs, QRGs, etc.)
to support labeling development in compliance with ISO, cGMP, and FDA guidelines, while working within established formats and templates.Identify areas for improvement (e.G., processes, styles, formats), and execute continuous improvement initiatives.Maintain a high level of quality, clarity, and consistency for all documents.Organize and maintain department files, databases, and spreadsheets.Represent the labeling function on core teams and coordinate with project teams to determine project and document requirements.Conduct interviews with subject matter experts or partners to gather data and understand scope, requirements, risk mitigations, etc.Initiate the collaborative review process.Demonstrate commitment to the development, implementation and effectiveness of the Quality Management System per ISO, FDA, and other regulatory agencies