Labeling Specialist Job in Irwindale, California US
Biosense Webster, Inc (BWI), a member of Johnson Johnson's Family of Companies, is recruiting for a Labeling Specialist, to be located in Irwindale, California.
Biosense Webster, Inc, is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes.
The Labeling Specialist serves as a labeling/documentation expert for all product labeling and documentation at Biosense Webster. Duties include the creation and revision of change control packages, product labels, packaging designs and instructions for use (IFU) for both the US and international markets. This individual will adhere to standard operating procedures, JJ corporate policies and government regulatory policies relating to product labeling. This individual will design product labels and generate and release product labeling changes which include artwork, labels, IFUs and manuals. The Labeling Specialist will generate Engineering Change Orders (ECOs) to implement new/revised labeling and procedures. This individual will act as liaison and develop relationships with translation agencies, in-country affiliate reviewrs (ICR), corporate attorneys and international regulatory staff. This individual will act as the liaison with OEM suppliers, vendors, and internal associates to control OEM labeling and will be the point of contact for labeling related projects at BWI. The Labeling Specialist will review and edit technical documentation such as IFUs and system manuals. This individual will also investigate and resolve CAPAs related to labeling and documentation.
Qualifications
A minimum of a Bachelors degree is required. A focused degree in Science, English, Technical Writing or related discipline is highly preferred. A minimum of 2 years of experience in a technical writing, medical device or equivalent field is required. Experience managing projects is required. Experience with Microsoft Office Toolset, enLabel, Photoshop, Illustrator and InDesign is preferred. Familiarity with Change Order/Change Control Systems and Product Labeling Systems is required.
Strong attention to detail and accuracy is required. The ability to work with both non-technical business partners as well as technical professionals is required. Strong analytical skills are preferred. Excellent written and verbal communication skills are required. The ability to quickly adapt and navigate various technology and computer software is required. The ability to work in a fast paced environment with rapidly shifting priorities is also required.
This position will require up to 10% travel and will be based in Irwindale, CA.
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