Regulatory Affairs Specialist

Sunnyvale, CA

Post Date: 07/12/2018 Job ID: RMA 5317 Position Categories: Manufacturing: Quality Assurance Pay Rate: Depending on experience

A biotech manufacturing company in Sunnyvale, CA is looking for a Regulatory Affairs Specialist.

Responsibilities:

  • Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies.
  • Investigates and resolves compliance problems, questions and complaints.
  • Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes.
  • Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products.

Bachelor's degree or equivalent

2-5 years in Quality and/or Regulatory Affairs in IVD/Medical Device Industry

Understanding of federal/state/international regulations

Attention to details

PREFERRED REQUIREMENTS:

Experience with IVD products and 510(k) and/or PMA (including annual reports, supplements)

Proficiency with Agile Product Lifecycle Management

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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