Regulatory Affairs Specialist

Job Description

Organization: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 241098
Primary Location: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%

Job Description:

Siemens US Talent Acquisition



Position Overview

The RA Specialist 3 is a member of the international RA team and responsible for providing documentation for registration of assays and supplementary products worldwide.

  • Prepares regulatory submission dossiers for assays and complimentary products in the LD product portfolio with key focus on Clinical Chemistry and Immunoassay reagents.
  • Reviews and provides supporting documents (test reports, labeling, others).
  • Reviews, updates and requests US FDA Certificates to Foreign Governments.
  • Writes and provides letters of explanation or country specific documents.
  • Supports the international RA team in other projects and tasks as assigned.

Responsibilities


  • Overall responsibility - prompt submission of registration documents to regional units RA members.
  • Expedites product change notifications, market expansion requests and serves as a liaison between Siemens and OEMs / 3rd Party Manufacturers RA professionals.
  • Maintains accurate productivity/activities metrics. 

Required Knowledge/Skills, Education, and Experience


  • Education - Bachelor of Science.
  • Technical proficiency - Basic knowledge of scientific and statistical terms.
  • Industry/business acumen - knowledge of regulatory affairs activities in medical devices and/or IVDs.
  • Work experience - Five or more years in regulatory affairs with experience in product submissions, international registration dossiers.
  • Knowledge, skills, or expertise - Proficient in Teamspace, Outlook, Word, Excel.
  • Excellent communication skills, verbal and written.
  • Amount of travel with the position - 5%

Preferred Knowledge/Skills, Education, and Experience


  • Education - science degree in laboratory science (i.e. Medical Technologist)
  • Past experience - over five years experience in regulatory affairs activities which include product submission, product launch planning, others.
  • Knowledge of IVDs
  • Experience communicating with non-English speaking colleagues.

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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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