Our mid-sized client is adding a Regulatory Affairs Specialist to join their team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed.  The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific products and ensures compliance with required regulations and established corporate standards.  

Your role with the company: 

• Preparing documentation for international regulatory registrations and renewals.
• Defining worldwide regulatory requirements necessary for regulatory approval of assigned products.
• Executing product submission strategies as directed.
• Maintaining all regulatory documentation to ensure availability for external audits and preparation of submission packages.
• Maintaining a thorough knowledge of current regulatory requirements.
• Executing on additional responsibilities as defined by management.

Desired Profile:

• Bachelor’s Degree in Science, Engineering, or other relevant discipline.
• 1+ years’ experience in Regulatory Affairs in the medical device industry.
• 1+ years’ experience in international registrations.
• Working knowledge of quality system regulations and guidelines.
• Great communication skills with all levels of personnel.
• High level of organization and planning skills.
• Working knowledge of medical devices, procedures, and terminology.