Associate Scientist - Infectious Disease
Responsible for collating, reviewing and writing analytical documentation to enable products to meet the requirements of Regulation (EU) 2017/746 (IVDR).
ESSENTIAL JOB RESPONSIBILITIES:
- Collate information and data into comprehensive written reports and plans that will be required to complete technical documentation files.
- Responsible for identifying and reviewing available documents for each product.
- Responsible for identifying any gaps in documentation or data and bringing them to the attention of management.
- Coordinate with cross-functional teams to obtain required documentation and files.
Education and Experience (in years):
- PhD or MS with ≥ 5 years’ industrial experience
Knowledge and skills:
- Excellent technical writing skills and ability to review and summarize data into clearly written and concise reports
- Experience with in vitro diagnostic products and molecular technologies especially PCR assay optimization
- Understanding of the product development cycle especially design verification
- Ability to work effectively in cross-functional teams
- Strong inter-personal skills and an ability to comprehend and effectively communicate technical ideas and concepts to a diverse audience
- Experience working in an FDA/ISO regulated environment.
- Ability to work well under pressure to meet strict deadlines.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.