Temporary Regulatory Affairs Specialist

Job Summary

Acting as the regulatory representative on product development teams, the temporary Regulatory Affairs Specialist will ensure compliance for instrument and software development and manufacturing while maintaining regulatory documentation and participating in audits.

Key responsibilities

• Maintain Regulatory Affairs documents, policies, and procedures to support compliance with regulatory requirements
• Review labeling and promotional materials to ensure regulatory compliance and represent Regulatory Affairs in project team meetings
• Assist in the interpretation and submission of domestic and international regulatory registrations and manage the execution of regulatory plans

Required qualifications

• BA/BS degree is required
• 2-5 years of hands-on experience in Regulatory Affairs
• Working knowledge of FDA QSR, ISO 13485, and ISO 9001 regulations
• Previous in vitro diagnostic (IVD) nucleic acid experience is a plus
• Proven ability to work on product development teams