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Regulatory Affairs Professional 4

Job Description

Position Overview

  • The RA Specialist Level 4 is a member of the Tarrytown IA2 RA team and is responsible for developing global registration strategies and leading FDA and EU registrations for Atellica IM and ADVIA Centaur assays. 
  • Developing and executing regulatory strategies for assigned projects to successfully register IVDs in U.S., EU, Canada, Japan, China and worldwide. 
  • Serving as the Regulatory Affairs representative on product core teams to ensure the assays developed are high quality and have been tested according to worldwide regulatory requirements.
  • Reviewing technical plans and reports to ensure data accuracy, traceability and compliance to standards (e.g. ISO, CLSI).
  • Reviewing and approving product labeling, advertising/promotional material, verification plans and reports.
  • Participating in internal and external audits (as auditee and audit support).
  • Reviewing new regulations or guidance documents and assessing their impact to the business.
  • Developing new procedures or enhancing existing processes to facilitate efficient and effective business practices.
  • The position reports to the Director, Regulatory Affairs. 

Responsibilities

  • The RA Specialist Level 4 is a member of the Tarrytown IA2 RA team and is responsible for developing global registration strategies and leading FDA and EU registrations for Atellica IM and ADVIA Centaur assays.
  • Maintain good relationships within RA team and across other business functions (e.g. Marketing, R&D)
  • Developing and executing regulatory strategies for assigned projects to successfully register IVDs in U.S., EU, Canada, Japan, China and worldwide. 
  • Serving as the Regulatory Affairs representative on product core teams to ensure the assays developed are high quality and have been tested according to worldwide regulatory requirements.
  • Reviewing technical plans and reports to ensure data accuracy, traceability and compliance to standards (e.g. ISO, CLSI).
  • Reviewing and approving product labeling, advertising/promotional material, verification plans and reports.
  • Participating in internal and external audits (as auditee and audit support).
  • Reviewing new regulations or guidance documents and assessing their impact to the business.
  • Developing new procedures or enhancing existing processes to facilitate efficient and effective business practices.

Required Knowledge/Skills, Education, and Experience

  • Required education and focus

o   BS in Science, Engineering or related discipline

  • Required past experience
    • 7-10 years regulatory affairs experience with FDA and EU regulations.
    • Experience with immunoassays
    • Experience in assay development or in a technical role in manufacturing
    • Experience in laboratory environment
  • Required amount of travel with the position

o   None or very minimal (<10%)

  • Required knowledge, skills, or expertise
    • Good technical writing skills
    • Proficiency in reading, interpreting, and summarizing technical reports
    • Clear communication skills (both written and oral) and strong presentation skills, with a firm grasp of target audiences
    • Creative and adept at problem solving
    • 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 (including macros and Excel functions)
    • Demonstrated ability to complete assignments independently and in teams
    • Experience building consensus, presenting convincing arguments and overcoming objections
    • Strong scientific background and understanding how changes could impact assay performance.

Preferred Knowledge/Skills, Education, and Experience

  • MS in Science, Engineering or related discipline
  • Participation in industry groups and standard development committees
  • Bi-lingual
  • Intercultural sensitivity


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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