14 days old
2017-11-282017-12-28

Regulatory Technical Spec 2

Siemens
Tarrytown, NY
**Regulatory Technical Spec 2**







Locations:Tarrytown, New York











Job Family: Quality Management











Apply







English (US)



























**Job Description**















**Division:** Siemens Healthineers



**Business Unit:** Laboratory Diagnostics



**Requisition Number:** 217999



**Primary Location:** United States-New York-Tarrytown



**Assignment Category:** Full-time regular



**Experience Level:** Mid level



**Education Required Level:** Bachelor's Degree



**Travel Required:** 5%







**Division Description:**







siemens







**Job Description:**







+ Main objective of the position and the impact of the role: The RA Specialist Level 2 is a member of the TTN international RA team and is responsible for supporting international product registrations for ADVIA and Atellica products.



+ Brief description of the primary accountabilities of the role that will drive the future employee's performance objectives



+ Prepares and sends regulatory submission dossiers to Siemens regional units worldwide.



+ Sends Product Change Notifications, collates responses and follows through on completing necessary tasks.



+ Liaises with RA design change team members to obtain supporting documents (test reports, labeling, etc.).



+ Obtains Certificates (CFG, COE) to support registrations.



+ Liaises with Legal Department on country-specific letters.



+ Submits documents for legalization and manages the process.



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



+ Potential to lead international product registration projects and tasks as needed.



+ Brief description of where the position fits in the organization including the title of the direct manager and how that fits into the Business Unit/Division/Sector, and (if it's a manager position) the size of the team.Position reports to the Sr. Manager, Regulatory Affairs.























**Responsibilities**























In this section, please outline the specific responsibilities and deliverables associated with the role. These are the tasks that must be carried out by the person in this job. The bullets should be informative, detailed and succinct.











+ Overall responsibility what will the person have to accomplish in this role







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











+ Additional objectives of the position







+ Maintains existing PCN process.



+ Supports and completes product registrations through RAPID database.











+ Details of very specific job tasks and functions (5 to 10 bullets)







+ Prepares and sends regulatory submission dossiers.



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



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



+ Obtains Certificates (CFG, COE) to support registration.



+ Liaises with Legal Department on country-specific letters.



+ Submits documents for legalization and manages the process.



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



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































**Required Knowledge/Skills, Education, and Experience**























In this section, please outline exactly what knowledge/skills, education, and experiences are required to be considered for this position.











+ Required education and focus







+ Bachelors degree.











+ Required past experience (including number of years)







+ 3+ years regulatory affairs experience



+ Knowledge and experience with Medical devices or IVDs.



+ Experience with regulatory agencies.











+ Required amount of travel with the position







+ None or very minimal (<5%).











+ Required knowledge, skills, or expertise







+ Good focus with attention to detail



+ Willingness to learn to interpret technical reports



+ Knowledge of regulatory requirements worldwide



+ Creative and adept at problem solving



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



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































**Preferred Knowledge/Skills, Education, and Experience**























In this section, please outline exactly what knowledge/skills, education, and experiences are preferred but NOT required to be considered for this position.











+ Preferred education and focus (if applicable)







+ College degree in a scientific discipline.











+ Preferred past experience (including number of years)







+ Experience communicating with non-native English speakers



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











+ Preferred knowledge, skills, or expertise







+ Demonstrated interest in having a career in regulatory affairs.



+ Good technical writing skills



+ Intercultural sensitivity



+ 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 .

Share this job:

Regulatory Technical Spec 2

Siemens
Tarrytown, NY

Share this job

Regulatory Technical Spec 2

Siemens
Tarrytown, NY
US

Separate email addresses with commas

Enter valid email address for sender.

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast