?Role: Regulatory Affairs Associate

Location: Lake Forest, IL (Conway Park)

Duration: 12 Months

Job Description

The Regulatory Affairs Associate is responsible for managing applications and interactions with government agencies to obtain approvals for medical products.

?Key responsibilities include:

• Preparing and submitting PMA supplements such as 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
• Reviewing and approving engineering and validation study protocols/reports.
• Managing regulatory submissions and approvals for Class III implantable medical devices.
• Ensuring compliance with FDA PMA guidance documents and CFR regulations.

Qualifications

• Advanced degree preferred with 5-8 years of relevant experience.
• Proven track record in submitting and obtaining approvals for Class III implantable medical devices.
• Strong knowledge of FDA regulations and guidance documents for PMA submissions.
• Ability to plan and execute tasks with minimal supervision.
• Creativity and decision-making skills, with the ability to lead and collaborate effectively.