Product Labeling/ Project Specialist - Molecular Diagnostics Products
Business Unit: Strategic Procurement
Requisition Number: 230935
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
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
Product Labeling Specialist IV, Molecular Diagnostics
Siemens Healthineers, located in Berkeley, CA, is seeking a Product Labeling Specialist IV to manage product labeling projects for new and existing Molecular Diagnostic products. This position reports to the Head of Product Labeling for the Molecular Diagnostics business.
This position is an integral member of the Molecular Product Labeling group and ensures that product labeling requirements and deliverables are met for Molecular Diagnostic products and projects in accordance with Siemens Healthineers policies and procedures.
Key responsibilities of the Product Labeling Specialist IV:
Effectively work with the Molecular Product Labeling team to develop and maintain product labeling
Represent Molecular Product Labeling on project teams to define and support product labeling requirements
Manage labeling deliverables in accordance with project requirements
Facilitate clear communication amongst key stakeholders
Meet country-specific product labeling requirements to support business growth and compliance
Support quality systems for product labeling
The successful candidate will be a motivated team player with IVD or medical device experience, effective leadership and collaboration skills, relevant project management experience, and the ability to support the Siemens Healthineers business principles.
This position requires an in-depth knowledge of product labeling development, and technical writing or instructional design principles, tools, practices and procedures. Product labeling deliverables may include, but are not limited to product documentation, Instructions For Use, Operator’s Manuals, online help, release notes, product packaging, labels, and translations.
Education and Experience
A Bachelor’s degree or Master’s degree, preferably in areas of Life Sciences, Engineering, or Quality Assurance
8+ (BA/BS) or 5+ (MA/MS) years’ experience in management of technical writing or product labeling projects within an IVD-regulated environment
Familiarity with international regulations for IVD product labeling
Prior experience working with cross-functional project teams, suppliers, and business partners
Fluency with Microsoft Office, Microsoft Project, Microsoft Outlook, 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 in vitro diagnostic product 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
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 / medical device writing instructions for use, complex hardware operation and software procedures
Quality system experience with corrective and preventative actions (CAPAs) and issue resolutions (IRs)
Professional designations are not required, but training and certificates in quality or regulatory affairs is a plus (e.g., CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
Familiarity with international regulations for product labeling language requirements