Company overview
bvi ®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).
purpose
creates 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.
required knowledge, skills, and abilities
* working knowledge of barcode label printing software and printers
* advanced proficiency in adobe illustrator, indesign, teklynx/codesoft, sharepoint, prisym, bartender, salesforce, easy label, labeling design and qms/erp experience must be current and used in a professional setting, working knowledge of design programs
* possesses sufficient labeling acumen required to support technical activities such as running labeling approval process.
* knowledge of cgmp’s and fda/ce mark regulatory requirements.
* knowledge of microsoft office’s suite of products.
* ability to independently lead labeling process development.
* ability to independently lead technical assessment(s), generating, and documenting test plans and reports.
minimum required education and experience
* bachelor's degree or related field and five (3) years’ relevant experience; or equivalent combination of education, training and experience.
* bilingual (spanish & english)