Lab Techncian-Regulatory Affairs
A biotech manufacturing company in Sunnyvale, CA is looking for a Lab Technician for the Regulatory Affairs department. The department is responsible for interacting with the US Food and Drug Administration (FDA) and regulatory agencies in over 45 countries across the globe, to submit technical documentation and obtain registration licenses. The Regulatory Affairs department keeps abreast of changes to the regulatory landscape, and formulates a regulatory plan that feeds into the product development process. Demonstrating a product’s safety and efficacy, and successfully registering it with the appropriate regulatory agencies, are prerequisites for selling company’s products in the US and around the world.
- Perform product testing to support international registrations
- Draft and review test plans and generate test reports.
- Ordering, receiving, and maintaining an adequate supply of materials for product testing.
- Ship samples and keep track of the shipping status for materials shipped for clinical studies and in-country testing for different countries.
- Maintains clean and organized work areas, equipment, and devices.
Bachelor’s degree in a scientific field plus at least 2 to 3 years of lab experience is required
Knowledge of basic computer programs including Word, Excel, PowerPoint and Adobe Acrobat
Strong written and oral communication skills
Be able to lift 20lbs.
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.