Siemens Product Labeling Specialist IV, Molecular Diagnostics in Berkeley, California
Product Labeling Specialist IV, Molecular Diagnostics
Organization: Siemens Healthineers
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 healthcaretogether.
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 ProductLabeling team todevelop and maintain product labeling
Represent MolecularProduct Labelingon project teams to define andsupport product labeling requirements
Manage labeling deliverablesin accordance with project and regulatory requirements
Facilitate clear communication amongst keystakeholders
Meet country-specificproduct labeling requirements to support businessgrowth and compliance
Support quality systems forproduct 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.
E ducation 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 oftechnical writing or product labeling projects within an IVD-regulatedenvironment
Familiarity with international regulations for IVD productlabeling
Prior experience working with cross-functional project teams,suppliers, and business partners
Fluency with Microsoft Office, Microsoft Project, MicrosoftOutlook, and Adobe Acrobat
Agile and flexible team player with the ability to meet projecttimelines and complete product labeling deliverables to meet global productdemands
Understanding of regulations and guidelines governing the areas ofmedical device and in vitro diagnostic product development, with a broad knowledge of related topics suchas Quality Assurance, Manufacturing and Product Development
Proven ability to multitask, collaborate in cross-functionalteams, and work independently
Excellent working knowledge of English grammar, punctuation andoverall writing skills
Critical-thinker with the ability to address complex situations,issues, and adopt a systemic view of continuous process improvement to reachgoals
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 certificatesin quality or regulatory affairs is a plus ( e.g . , CQM, CQE, CQA, RAC, CLIA, Six Sigma,Lean Principles)
Familiarity with international regulations for product labelinglanguage 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 healthcareis 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.
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .
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