Regulatory Technical Specialist 3 [Walpole,Ma.][Mfg]195509

Job Description

  • The RA Specialist Level 3 is a member of the TTN international RA team, will be located at Walpole Massachusetts manufacturing site, and is responsible for supporting international product registrations for Atellica Solutions, ADVIA Centaur, and next generation products. 
  • Primary accountabilities of the role that will drive the future employee's performance objectives 
    • Responsible for efficient tracking of registration requests for Walpole site documents.
    • Supports strategy and implementation of document redaction process including providing guidance and training.
    • Leads bi-weekly meeting to discuss status of requests
    • Maintains SharePoint site for document repository of manufacturing documents.
    • Supports registration projects related to new product registrations, license renewals, and re-registration requests via TeamSpace.
    • Liaises with manufacturing site colleagues to obtain required information and documents.
    • Various interdepartmental communications with regulatory affairs, manufacturing, R&D, and labeling, and others to support an efficient and effective international product registration process.
  • The position reports to the Sr. Manager, Regulatory Affairs in Tarrytown, NY. 

Responsibilities


  • Overall responsibility — 

o    The RA Specialist Level 3 is a member of the TTN international RA team and is responsible for working together with manufacturing site colleagues to obtain documents required in support of international product registrations for Atellica Solutions, ADVIA Centaur, and next generation products. 

  • Additional objectives of the position
    • Interacts with other international RA colleagues at the site. 
    • Effective interdepartmental communications.
  • specific job tasks and functions 
    • Maintains effective tracking of requests for Walpole manufacturing site information and documents.
    • Supports strategy and leads document redaction process.
    • Trains other colleagues on document redaction process
    • Maintains and organizes SharePoint site document repository.
  • Supports projects related to new product registrations, renewals, and re-registrations due to product changes.
  • Liaises with regulatory affairs core team, design change team, and international RA team members to support product registrations worldwide.
  • Various interdepartmental communications with manufacturing, R&D, labeling, and others to support an efficient and effective international product registration process.


  • Required education and focus

o    Advanced degree

  • Required past experience (including number of years)
    • 4+ years regulatory affairs experience.
    • Knowledge and experience with manufacturing documents for IVDs. 
  • Required amount of travel with the position

o    None or very minimal (<5%).

  • Required knowledge, skills, or expertise
    • Good technical writing skills
    • Ability to read and interpret manufacturing documents
    • Knowledge of regulatory requirements worldwide
    • Creative and adept at problem solving
    • Effective communication skills
    • Great focus with attention to detail
    • Able to multi-task and work effectively in a dynamic environment
    • Skilled in Outlook, Adobe Acrobat and Microsoft Office applications
    • Able to work independently

Preferred Knowledge/Skills, Education, and Experience


  • Preferred education and focus (if applicable)

o    College degree in a scientific discipline.

  • Preferred past experience (including number of years)
    • Experience with manufacturing documents
    • Experience in laboratory and/pr manufacturing environment (e.g., Med Tech background)
  • Preferred knowledge, skills, or expertise
    • Understanding manufacturing process/documents
    • Leadership skills


Job ID: 195509

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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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.

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