Global Medical Devices Regulatory Affairs Associate

Unicon Pharma Inc; Lake Forest (IL); On-site; USD 85,000 - 120,000; Part time

Job summary

A leading pharmaceutical company located in Lake Forest, Illinois, is seeking a Senior Pharmaceutical Recruiter. The ideal candidate will provide regulatory support for both U.S. and global medical device submissions, focusing on compliance with FDA and EU requirements. Responsibilities include preparing registration packages, maintaining global regulatory dossiers, and collaborating across functions to resolve documentation issues. A Bachelor's degree and at least 2 years of experience in Regulatory Affairs within the medical device field are essential.

Qualifications

• Minimum of 2 years of experience in Regulatory Affairs in medical devices.
• Experience with FDA and EU regulatory submissions.
• Ability to identify documentation gaps and resolve issues.

Responsibilities

• Provide regulatory support for U.S. and global medical device submissions.
• Prepare registration packages and maintain global regulatory dossiers.
• Support execution of regulatory strategies and ensure compliance.

Skills

Regulatory Affairs expertise

Cross-functional collaboration

Documentation management

Education

Bachelor's degree

Job description

A leading pharmaceutical company located in Lake Forest, Illinois, is seeking a Senior Pharmaceutical Recruiter. The ideal candidate will provide regulatory support for both U.S. and global medical device submissions, focusing on compliance with FDA and EU requirements. Responsibilities include preparing registration packages, maintaining global regulatory dossiers, and collaborating across functions to resolve documentation issues. A Bachelor's degree and at least 2 years of experience in Regulatory Affairs within the medical device field are essential.