Our mid-sized client is adding a Regulatory Affairs Specialist 2 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.
• 4+ years’ experience in Regulatory Affairs in the medical device industry.
• 1-3 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.