Regulatory Affairs Mfg Consultant

Description

This position is responsible for the preparation of International regulatory submissions required to market new or modified medical devices in Outside of the US (OUS).

Requires the analysis of data, problem solving analysis, in depth evaluations of various factors and project management.

Essential to guide OUS) registrations to completion in a timely manner, status reporting will be necessary.

Qualifications

• Experience in preparing and submitting international regulatory submissions for medical devices
• Knowledge of FDA and other international regulatory requirements
• Strong analytical and problem-solving skills
• Project management experience

Skills

• Regulatory Affairs
• Medical Device Compliance
• International Regulatory Submissions
• Data Analysis
• Problem Solving

Benefits

• Flexible schedule
• Competitive compensation package
• Professional development opportunities

Pay

$60,000 - $70,000 annually

Schedule

1st Shift (8-9am to 4-5pm)