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