Siemens Regulatory Technical Spec 3 in Tarrytown, New York

Regulatory Technical Spec 3

Locations:Tarrytown, New York

Job Family: Quality Management

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Job Description

Division: Siemens Healthineers

Business Unit: Laboratory Diagnostics

Requisition Number: 200329

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 TTN international RA team and is responsible for supporting international product registrations for ADVIA products.

o Creates and implements strategies to support Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America and Europe in registering ADVIA products with special focus on China.

o Provides answers to technical questions from international regulatory authorities.

o Prepares and provides technical documents (test reports).

o Leads projects related to new product registrations, license renewals, and re-registration requests using RAPID database.

o Liaises with RA core team and design change team members to support product registrations worldwide.

o 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

o The RA Specialist Level 3 is a member of the TTN international RA team and is responsible for supporting international product registrations for ADVIA products.

o Interacts with other international RA colleagues to establish best practices.

o Effective interdepartmental communications.

o Organizes and sends international regulatory submission dossiers for ADVIA product line.

o Creates and implements strategies to supports Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America and Europe in registering ADVIA products with specific focus on China.

o Provides answers to technical questions from international regulatory authorities.

o Prepares and provides technical documents (test reports).

o Leads projects related to new product registrations, license renewals, and re-registration requests using RAPID database.

o Liaises with RA core team and design change team members to support product registrations worldwide.

o 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

o Advanced degree

o 4+ years regulatory affairs experience.

o Knowledge and experience with global registrations of IVDs.

o None or very minimal (<5%).

o Good technical writing skills

o Ability to read and interpret technical reports

o Knowledge of regulatory requirements worldwide

o Creative and adept at problem solving

o Effective communication skills

o Great focus with attention to detail

o Able to multi-task and work effectively in a dynamic environment

o Skilled in Outlook, Adobe Acrobat and Microsoft Office applications

o Able to work independently

Preferred Knowledge/Skills, Education, and Experience

o Advanced degree in a scientific discipline.

o Experience communicating with non-native English speakers

o Experience in laboratory environment (e.g., Med Tech background)

o Bi-lingual, preferably mandarin

o Intercultural sensitivity

Siemens encourages qualified long-term unemployed individuals to apply for open positions.

Offer of employment with Siemens is conditioned upon the successful completion of a background check and drug screen, subject to applicable laws and regulations.

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, disability status, 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. Click at http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm here at http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm to learn more. at http://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. Click at http://www.dol.gov/ofccp/pdf/PayTransparencyNoticeJRFQA508c.pdf here at http://www.dol.gov/ofccp/pdf/PayTransparencyNoticeJRFQA508c.pdf to learn more. at http://www.dol.gov/ofccp/pdf/PayTransparencyNotice_JRFQA508c.pdf

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/PayTransparencyNotice_JRFQA508c.pdf .