Siemens Regulatory Technical Spec 2 in Tarrytown, New York

Regulatory Technical Spec 2

Locations:Tarrytown, New York

Job Family: Quality Management

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English (US)

Job Description

Division: Siemens Healthineers

Business Unit: Laboratory Diagnostics

Requisition Number: 231382

Primary Location: United States-New York-Tarrytown

Assignment Category: Full-time regular

Experience Level: Mid level

Education Required Level: Bachelor's Degree

Travel Required: No

Division Description:

siemens

Job Description:

Responsibilities

o The RA Specialist Level 2 is a member of the TTN international RA team and provides support for the registration of ADVIA products worldwide.

o Manage existing PCN process.

o Supports and completes product registrations through RAPID database.

o Prepares and sends regulatory submission dossiers for ADVIA product line.

o Sends Product Change Notifications to Siemens RU worldwide, collates responses and follows through on completing necessary tasks.

o Provides supporting documents (test reports, labeling, etc.).

o Obtains Certificates (CFG, FSC) to support registration.

o Liaises with Legal Department on country-specific letters.

o Submits documents for legalization and manages the process.

o Reviews and prepares China-specific registration letters, manages the process of notarization and sending documents.

o Able to work independently on international product registration projects and tasks as needed.

Required Knowledge/Skills, Education, and Experience

o Bachelor’s degree.

o 3+ years regulatory affairs experience

o Knowledge and experience with Medical devices or IVDs.

o Experience with regulatory agencies.

• Required amount of travel with the position

o None or very minimal (<5%).

o Good focus with attention to detail

o Willingness to learn to interpret technical reports

o Knowledge of regulatory requirements worldwide

o Creative and adept at problem solving

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

o Skilled in Outlook, Adobe Acrobat and Microsoft Office applications.

Preferred Knowledge/Skills, Education, and Experience

o College degree in a scientific discipline.

o Experience communicating with non-native English speakers

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

o Demonstrated interest in having a career in regulatory affairs.

o Good technical writing skills

o Intercultural sensitivity

o Bilingual

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 .