Responsibilities
- Member of the international RA team and responsible for preparing and providing documents for registering assays and complementary products worldwide and collaborating with marketing in market expansion projects.
- Assists in the preparation of regulatory submission dossiers for assays in the Laboratory Diagnostics product portfolio with key focus on Clinical Chemistry and Immulite portfolio.
- Participates in meetings to review market expansions / compliance requests for Siemens and 3rd party manufacturers.
- Works in the RAPID and Sharepoint collaboration tools to upload and exchange documents with the Country RA.
- Obtains Certificates (CFG, FSC) to support registration.
- Liaises with Legal Department on country-specific letters.
- Submits documents for legalization/apostille and manages the process.
- Provides country-specific letters and letters of explanation.
- Support the International RA team in other projects and tasks as needed.
Required Knowledge/Skills, Education, and Experience
- College degree
- Three years’ experience with medical devices - IVDs.
- One year’ experience in regulatory affairs.
- None or very minimal Travel(<5%).
- Technical knowledge of IVD products, claims and data.
- Good English writing skills. Able to write clear and concise explanation to bridge gaps between existing documents and country requirements.
- Knowledge of regulatory requirements for IVDs.
- Attention to detail
- Creative and adept at problem solving
- Able to multi-task and work effectively in a dynamic environment
- Skilled in Outlook, Adobe Acrobat and Microsoft Office applications, specifically in Excel – knows how to conduct v-lookups, pivot tables, conditional formatting.
Preferred Knowledge/Skills, Education, and Experience
- College degree in a scientific discipline.
- Experience in laboratory environment (e.g., Med Tech background)
- Technical knowledge of Clinical Chemistry products.
- Knowledge of Sharepoint as a user.
- Intercultural sensitivity.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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