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Regulatory Affairs Professional

Job Description

Main objective of the position and the impact of the role:  The objective is to support international product registrations for newly launched and currently marketed products to reduce time to registration completion. 
• Brief description of the primary accountabilities of the role that will drive the future employee's performance objectives  
o Supports worldwide product registrations by providing information and documents to Siemens Regional Unit (RU) in Asia-Pacific, Middle East Asia, South and Latin America and Europe.
o Provides answers to technical questions from Siemens Regional Unit (RU) and international regulatory authorities. 
o Prepares and/or compiles technical documents for the global dossier and country specific requirements.    
o Supports projects related to new country and new product registrations, as well as license renewals, and re-registrations due to product changes.
o Liaises with Regulatory Affairs (RA) core team, design change team, and international RA members to support product registrations worldwide.
o May have various interdepartmental communications with marketing, manufacturing, R&D, Original Equipment Manufacturers (OEM) labeling, and others to support an efficient and effective international product registration process. 
o Managing a team of RA professionals
• Description of reporting structure. 
o Reports to an in-country regulatory affairs supervisor.
o Specific tasks are assigned by the business area LD QT RA.

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 
o College degree 
• Required experience (7+ years)
o Technical background in IVD and/or immunology 
o Professional experience in regulated industry  
• Required amount of travel with the position
o None 
• Required knowledge, skills, or expertise
o Ability to learn quickly and apply the information to assigned tasks
o Good technical writing skills
o Ability to read and understand technical data/reports
o Creative and adept at problem solving
o Effective communication and organization skills
o Great focus with attention to detail
o Able to multi-task and work effectively in a dynamic environment
o English speaking and writing
o Skilled in Outlook, Adobe Acrobat and Microsoft Office applications
o Able to work independently and within a team

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)
o Bachelor’s degree or higher in a scientific discipline.
• Preferred experience (7+ years)
o Knowledge and experience with global registrations of IVDs
o Experience communicating with non-native English speakers
o Experience in laboratory environment (e.g., Med Tech background)
• Preferred knowledge, skills, or expertise
o Knowledge of regulatory requirements worldwide
o Bi-lingual
o Intercultural sensitivity
o Skilled in databases such as SAP, SharePoints, OneNote, etc.


Organization: Siemens Healthineers

Company: Siemens Healthineers India LLP

Experience Level: Experienced Professional

Job Type: Full-time

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