Regulatory Affairs Specialist

Sunnyvale, CA

Posted: 04/08/2019 Position Categories: Science

A biomedical manufacturing company located in Sunnyvale, CA is seeking a regulatory Affairs specialist. The Regulatory Affairs 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 the company’s products in the US and around the world. As a part of the International Regulatory Affairs group, the Regulatory Affairs Intern will work on a well-defined time-bound project to streamline the company's regulatory documentation processes and to ensure that documents are furnished in a timely manner to international regulatory agencies.

Responsibilities include:

  • Review, edit and proofread regulatory documentation
  • Compile, under supervision, regulatory documents for submission
  • Compile and prepare responses to questions from regulatory authorities as required
  • Assist in data entry and database audit of the regulatory affairs database for accurate tracking of regulatory product status worldwide
  • Maintain awareness of regulatory requirements
  • May be responsible for a specific country/project

Bachelor’s or Master’s degree within a scientific discipline - Chemistry, Biology, Quality/Regulatory or related field.

Knowledge of basic computer programs including Word, Excel, PowerPoint and Adobe Acrobat

Strong written and oral communication skills

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.

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