Product Labeling Specialist II - Molecular IVD
Business Unit: Strategic Procurement
Requisition Number: 221864
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthineers
Seeking a Product Labeling Specialist to contribute to Siemens Healthineers Molecular Diagnostics R&D Business located in Berkeley, CA. The Product Labeling Specialist is part of the Molecular Product Labeling group, which ensures all product labeling requirements are met for new Molecular Diagnostic products and for existing product changes. The successful candidate is a motivated team player with strong collaboration skills, able to meet project timelines, assure compliance with regulatory requirements, and support the Siemens Healthcare business principles. Also possess strong leadership skills with prior product labeling development experience working within a Quality System in order to effectively support operations. This position reports to the Sr. Manager of Molecular Product Labeling for the Siemens Molecular Diagnostics business.
Content development of end-user instructions, operator’s manuals, and other products.
Represent Molecular Product Labeling on new product development teams, manage labeling projects, and be responsible for the creation and maintenance of product labeling content.
Facilitate clear communication amongst key stakeholders throughout the product lifecycle and meet country-specific product labeling requirements to support business growth and compliance.
Required Knowledge/Skills, Education, and Experience
A Bachelor’s degree, preferably in areas of life sciences, engineering, or quality assurance.
2+ years of technical writing, product labeling, quality, and/or regulatory project experience within an IVD-regulated environment.
In-depth knowledge of technical writing or instructional design principles, tools, practices and procedures. (Content deliverables may include product documentation, end-user instructions (IFUs and Product Inserts), Operator’s Manuals, online help, and release notes).
Familiarity with international regulations for IVD product labeling.
Prior experience working with cross-functional project teams, suppliers, and business partners.
Fluency with Microsoft Office and Adobe Acrobat.
Agile and flexible team player with the ability to meet project timelines and complete product labeling deliverables to meet global product demands.
Understanding of regulations and guidelines governing the areas of medical device and diagnostic development, with a broad knowledge of related topics such as Quality Assurance, Manufacturing and Product Development.
Proven ability to multitask, collaborate in cross-functional teams, and work independently.
Excellent working knowledge of English grammar, punctuation and overall writing skills, with the ability to edit content for user-facing documentation.
Critical-thinker able to address complex situations, issues, and adopt a systemic view of continuous process improvement to reach goals.
Preferred Knowledge/Skills, Education, and Experience
Experience in IVD or medical device writing instructions for use, complex hardware operation, and software procedures, or project-development projects preferred.
Quality system experience with corrective and preventative actions (CAPAs) and issue resolutions (IRs) preferred.
Familiarity with international regulations for product labeling language requirements.
Working knowledge of Framemaker, content management systems, SAP, Documentum, and SharePoint.