The Senior Regulatory Affairs Specialist is an incredible opportunity to join a fast-growing global medical device company.

This position is responsible for urgent regulatory affairs projects, and requires strong technical knowledge and ability to work with the engineering team. This position is located in the Western suburbs.

Responsibilities

• Ensure compliance and approve reports.
• Lead regulatory affairs projects.
• Prepare submissions to regulatory agencies.
• Collaborate across all departments and with all levels within the organization.
• Develop plans for complicated projects
• Stay updated on on future regulatory trends.
• Review all marketing material and product labeling to ensure compliance. Qualifications:

• Must have at least 4 years of experience working with the FDA and international regulatory.
• Bachelor’s degree. MBA preferred.
• Knowledge and of international regulations, as well as US Class II and III devices