A Remote Regulatory Affairs Specialist role in Cincinnati, Ohio is now available through Adecco Medical and Science.
In this role, you will assume the responsibility for regulatory compliance of a portfolio of medical devices used with the organization’s contrast media.
The Regulatory Affairs personnel in the Cincinnati office are responsible for assembling dossiers for global submissions worldwide of the organization’s LF device line.
Please note this is a long-term contract position starting in October 2022.
You will be able to work remotely as long as you reside in the eastern and central time zones.
Job Responsibilities
• Prepare domestic and international submissions for new products and product changes to facilitate timely approval of market access.
Communicates directly with US and international affiliates and regulatory personnel.
• Author dossier content for new device registrations and variations.
• Provide support to new and currently marketed products including labeling advice and post market follow up activity requirements.
Update of Technical Files and Design Dossiers as required along with developing strategy and creation of change notifications to regulatory agencies.
• Provide regulatory assessments for manufacturing change controls.
• Document Regulatory Activities and Approvals to support Global Market Authorizations.
Ensure files maintain compliance with regulatory requirements.
• Acts as a liaison with other departments, e.g., Quality, R&D, supply chain, marketing, materiovigilance and medical affairs for support of major initiatives.
• Support internal and external audits/inspections as required (EU notified bodies, FDA, etc.).
• Responsible for communicating business related issues or opportunities to the next management level.
Minimum Requirements
• Bachelor’s degree preferably in biological field, engineering, medical sciences, or material science discipline preferred
• Minimum 2-4 years’ work experience in Medical Device Regulatory Affairs.
• Good understanding of US, EU, Canada regulations on medical devices.
• Superior attention to detail.
• Excellent technology skills, particularly expertise with Microsoft Office (Word, Excel, etc.) applications.
• Strong written and verbal communication skills.
• Able to multitask effectively and work independently with international oversight.
• Experience with medical device product registration and licensing is preferred.
• Good record keeping skills.
• Ability to handle multiple tasks/ projects.