What are the responsibilities and job description for the Regulatory Affairs Specialist position at Automated Systems Inc.?
Regulatory Affairs Specialist – Medical Device Manufacturer
Location: Gurnee, IL
Work Environment: Hybrid
Contract: 3 months, with potential for extension
Position Overview:
Automated Systems, Inc. is seeking a Regulatory Affairs Specialist to support a leading medical device manufacturer. This contract role requires an experienced professional with a strong understanding of global regulatory requirements and documentation processes. The individual will play a critical role in ensuring timely product release, maintaining compliance, and supporting international registration efforts.
Key Responsibilities:
Order Release and ERP Hold Management:
· Assist in the daily review and release of orders placed on hold due to ERP registration restrictions.
· Use internal tools and established procedures to ensure compliance with regulatory and quality standards.
Document Preparation and Dossier Development:
· Gather required documentation and assist in the drafting of regulatory dossiers for international registrations.
· Ensure that documentation meets applicable regulatory requirements and guidelines for target markets.
Technical Documentation Review and Completion:
· Complete and maintain technical documentation for review and approval.
· Leverage existing records, technical files, and quality system documents to ensure completeness and accuracy.
Regulatory Compliance Support:
· Collaborate with internal departments (Quality, Manufacturing, and Supply Chain) to ensure alignment with regulatory requirements.
· Monitor and maintain compliance with applicable FDA, ISO, and international regulatory standards.
Qualifications:
Education:
· Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
Experience:
· Minimum of 3-5 years of regulatory affairs experience in the medical device industry.
· Proven experience working with ERP systems to manage registration holds and product releases.
· Experience preparing and submitting international registration dossiers (EU, LATAM, APAC, etc.).
Knowledge & Skills:
· Strong knowledge of FDA, ISO 13485, and global medical device regulatory requirements.
· Excellent document management skills, with the ability to work with technical files and quality documentation.
· Ability to analyze regulatory data and identify potential compliance risks.
· Strong organizational and communication skills to collaborate with cross-functional teams.
Job Types: Full-time, Contract
Pay: $45.00 - $65.00 per hour
Expected hours: 40 per week
Benefits:
- Health insurance
- Paid time off
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- No weekends
Work Location: Hybrid remote in Gurnee, IL 60031
Salary : $45 - $65
