- 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
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.
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.
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.