Regulatory Affairs Associate

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

Benefits offered by this job

Health insurance

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.
• Identify documentation gaps and collaborate cross-functionally to resolve issues.

Skills

Regulatory Affairs expertise

Cross-functional collaboration

Documentation management

Education

Bachelor's degree

Job description

Senior Pharmaceutical Recruiter – Unicon Pharma Inc

Regulatory Affairs Specialist

Provide regulatory support for U.S. and global medical device submissions, including FDA and EU requirements.

Prepare and organize registration packages and maintain global regulatory dossiers.

Support execution of global regulatory strategies and ensure compliance for submissions and change management.

Identify documentation gaps and collaborate cross-functionally to resolve issues.

Qualifications: Bachelor's degree required; 2+ years Regulatory Affairs experience in medical devices (RAC preferred).

• Seniority level: Associate
• Employment type: Contract
• Job function: Analyst
• Industries: Medical Equipment Manufacturing and Pharmaceutical Manufacturing