Regulatory Affairs Professional Details

Regulatory Affairs Professional

Siemens - Newark, DE

Employment Type : Full-Time

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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