Sr. RA Specialist

3 weeks ago


Irvine, United States Tandym Group Full time

A recognized services company in California is currently seeking an experienced Regulatory Affairs Specialist to join their staff in the Greater Los Angeles area in a Senior-level position.

Responsibilities:

The Senior Regulatory Affairs Specialist will:

  • Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies
  • Maintain company registrations and device listings in the US, Canada, and the EU
  • Analyze and reports department metrics
  • Perform and support internal, external, and third-party audits.
  • Evaluate compliance with applicable regulations, project policies, and procedures
  • Review and write standard operating procedures (SOPs) and other RA/QA policies, as necessary
  • Compose audit plans and reports
  • Conduct audits and inspections of GMP and non-regulated documentation
  • Track internal and external corrective and preventive actions
  • Perform other duties, as needed
Qualifications:
  • 5+ years of experience in Regulatory Affairs
  • Knowledge and understanding of related State and Federal regulations and procedures
  • Knowledge of FDA 510K and ISO 13485 Standards
  • Knowledge of Regulatory Affairs regulations, guidance, and procedures
  • Microsoft Office proficient
  • Solid analytical, quantitative and problem solving skills
  • Great interpersonal skills
  • Excellent communication skills (written and verbal)
  • Strong attention to detail
  • Highly organized
Desired Skills:
  • Bachelor's Degree
  • Certification in Regulatory Affairs and Auditing


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