Regulatory Affairs Specialist

Regulatory Affairs Specialist job description: The role involves providing regulatory assessments of manufacturing, design, material, and labeling changes, participating in Change Development Process meetings, and delivering written assessments to document regulatory impact. The candidate will also serve as a RA team member on assigned business projects, review and approve advertising and promotional materials, and review and approval of product labelling.

Requirements

• Regulatory Affairs contracted professional with experience working on product development teams
• Familiarity with FDA regulations for medical devices
• Submission experience of 510(k)s
• Familiarity with ISO 14971, U.S. regulation 21 CFR 820, EC Directives 93/42/EEC as amended by Directive 2007/47/EC, EN ISO 13485

Benefits

• Referral bonus of $500 per candidate