Siemens Regulatory Technical Spec 2 in Tarrytown, New York
Regulatory Technical Spec 2
Locations:Tarrytown, New York
Job Family: Quality Management
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
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
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 .