Siemens Careers

Regulatory Technical Specialist 3

Tarrytown, New York
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 237871
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Master's Degree
Travel Required: 5%

Division Description:

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/healthcare


Job Description:

 
Position Overview
 
The RA Specialist Level 3 is a member of the Tarrytown International RA team and is responsible for supporting international product registrations for Atellica Solutions and ADVIA Centaur products. 
  • Creates and implements strategies to support Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America and Europe in registering Atellica Solutions and ADVIA Centaur products.
  • Provides answers to technical questions from international regulatory authorities.
  • Prepares and provides technical documents (test reports).    
  • Leads projects related to new product registrations, license renewals, and re-registration requests via TeamSpace.
  • Liaises with RA core team and design change team members to support product registrations worldwide.
  • Various interdepartmental communications with marketing, manufacturing, R&D, OEMs, labeling, and others to support an efficient and effective international product registration process.
  • The position reports to the Sr. Manager, Regulatory Affairs. 
 
Responsibilities
    • The RA Specialist Level 3 is a member of the Tarrytown International RA team and is responsible for supporting international product registrations for Atellica Solutions and ADVIA Centaur products. 
  • Additional objectives of the position
    • Interacts with other international RA colleagues to establish best practices. 
    • Effective interdepartmental communications.
  • Organizes and sends international regulatory submission dossiers.
    • Creates and implements strategies to supports Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America, and Europe.
    • Provides answers to technical questions from international regulatory authorities.
    • Prepares and provides technical documents (test reports).   
  • Leads projects related to new product registrations, license renewals, and re-registration requests using RAPID database.
  • Liaises with RA core team and design change team members to support product registrations worldwide.
  • Various interdepartmental communications with marketing, manufacturing, R&D, OEMs, labeling, and others to support an efficient and effective international product registration process.
     
 
 
Required Knowledge/Skills, Education, and Experience
 
Required education and focus
    • Advanced degree
  • Required past experience (including number of years)
    • 4+ years regulatory affairs experience.
    • Knowledge and experience with global registrations of IVDs. 
  • Required amount of travel with the position
    • None or very minimal (<5%).
  • Required knowledge, skills, or expertise
    • Good technical writing skills
    • Ability to read and interpret technical reports
    • Knowledge of regulatory requirements worldwide
    • Creative and adept at problem solving
    • Effective communication skills
    • Great focus with attention to detail
    • Able to multi-task and work effectively in a dynamic environment
    • Skilled in Outlook, Adobe Acrobat and Microsoft Office applications
    • Able to work independently
 
Experience communicating with non-native English speakers
    • Experience in laboratory environment (e.g., Med Tech background)
  • Preferred knowledge, skills, or expertise
    • Bi-lingual, preferably mandarin
    • Intercultural sensitivity
       
 
 
 


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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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