Global Regulatory Affairs Specialist

AirClean Systems; Brecksville (OH); On-site; USD 75,000 - 110,000; Full time

Job summary

AirClean Systems in Brecksville, Ohio, is seeking a Regulatory Affairs Specialist to prepare submissions to FDA and international bodies and to ensure ongoing compliance across regions. The role reports to the Director of Regulatory Affairs and does not supervise others.

You will maintain regulatory documentation, support procedure development, and coordinate with global teams to manage registrations and changes. Strong attention to detail and teamwork are essential.

Qualifications

• Minimum of 2 year college degree; Bachelor's degree or greater preferred.
• Relevant experience in medical, legal, or other regulated industry.
• Experience creating and revising labels and DFUs preferred.
• Knowledge of European, ISO 13485 and FDA regulations preferred.
• Knowledge of GMP requirements and international regulatory guidelines desirable.

Responsibilities

• Prepare and submit regulatory documentation to FDA, Notified Bodies, and Authorized Representatives.
• Prepare, maintain, and submit European Medical Device Directive/Regulation compliant Technical Files.
• Create/modify regulatory procedures to remain compliant with FDA, ISO, European, and other standards.
• Work with international department on regulatory filings for product registration in different countries.
• Provide regulatory support for other projects as required.
• Update personnel on new or revised processes and procedures.
• Process, organize and archive internal documentation related to Engineering/Quality Systems.
• Prepare change order documentation and route for final approval.

Skills

Communication across functions

Teamwork

Attention to detail

Regulatory knowledge

Education

Bachelor's degree or higher

Tools

Microsoft Office

Job description

AirClean Systems in Brecksville, Ohio, is seeking a Regulatory Affairs Specialist to prepare submissions to FDA and international bodies and to ensure ongoing compliance across regions. The role reports to the Director of Regulatory Affairs and does not supervise others.

You will maintain regulatory documentation, support procedure development, and coordinate with global teams to manage registrations and changes. Strong attention to detail and teamwork are essential.