Regulatory Affairs Specialist

hace 7 días


San Juan, San Juan, Puerto Rico Staar Surgical A tiempo completo

Job Summary
Staar Surgical is seeking a highly skilled Regulatory Affairs Intern to assist with FDA and international regulatory submissions. The ideal candidate will have a strong understanding of medical devices regulations and terminologies, as well as excellent written and oral communication skills.

Main Responsibilities
Assist with coordination of essential documents and tools for regulatory submissions
Conduct quality checks for compliance with applicable regulations
Prepare and maintain annual renewals of Establishment Registrations and other pertinent domestic and international licensing
Compile information necessary for periodic reports for Regulatory filings
Review and interpret regulatory rules and ensure they are included in company practices
Review complex reports and validations for scientific merit and regulatory appropriateness
Review and edit communications, including memos, correspondence, and presentations
Develop and review procedures for compliance with regulatory requirements
Participate in Health Authority Inspections and support remediation teams

Requirements
B.A./B.S. degree in Regulatory Science or related field
One or two years of work experience preferred
Strong knowledge of FDA and international regulations
Excellent written and oral communication skills
Ability to work in a team setting



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