Business Unit: Diagnostics
Requisition Number: 248551
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Job Title: Product Labeling Specialist IV, Molecular Diagnostics
Job Location: Berkeley, CA
Siemens Healthineers, located in Berkeley, CA, is seeking a Product Labeling Specialist IV to manage product labeling projects for new and existing products. This position reports to the Sr. Manager 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 Diagnostics 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 and regulatory 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, technical writing, and 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.
- 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 with the ability to address complex situations, issues, and adopt a systemic view of continuous process improvement to reach goals
- 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
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.