Regulatory Affairs Specialist (Medical Devices)

T-Biyoteknoloji

Qualifications:

• English verbal and writing proficiency is required.
• Excellent written and verbal communication skills are required
• Bachelor's Degree in a scientific field is required.
• More than 2 years of experience (CE Certification of IIa, IIb, III) is a plus.
• Medical Device industry experience is preferred.
• Ability to work as a member of a team in a timeline-driven environment with limited supervision is required
• A detail-oriented work ethic while handling multiple ongoing projects/tasks is required.
• Regulatory and systems training will be provided.
• Advanced Level of MS Office Programs
• For Male Candidates, Military service must be completed.

Responsibilities:

• Organize, retrieve, and distribute technical and specialized product regulatory information.
• Complete customer regulatory requests and approval forms using software resources
• Analyze regulatory information and determine corrective action for missing or incorrect data
• Maintain regulatory records, manage and update regulatory system data in various databases
• Assist sales in navigating regional and global regulatory issues and track customer requests
• Reports to and assists Regulatory Team Leader with the output of customer support documentation
• Follow up Medical Device Regulation and guidances (MDCG/IMDRF/TeamNB) to make up-to-date technical files.
• Contact with related departments to receive necessary information and/or documents.