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%
Siemens US Talent Acquisition
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.
- 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.