Senior Regulatory Affairs Specialist

·         Perform assigned regulatory activities including submissions/responses to country authorities.

Daily Responsibilities - Job Description suppliers should use:

·         Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.

·         Assist in strategy implementation and operations for Regulatory Affairs activities, including development of EU MDR Technical File submissions and responses to Notified Bodies.

·         Assist in maintaining Regulatory records and files.

·         Review product changes as assigned and assess required EU MDR submissions/notifications.

Educational Requirements:

·         BA Degree required, preferably in a science, engineering or technology discipline.

·         Work Experience Requirements: 3-5 years experiences in Medical Device Regulatory Affairs Top

Skills:

·         Strong oral communication and interpersonal skills

·         Proficient in technical writing

·         Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.

·         MS Office Suite including an Intermediate level with Excel using Pivot Tables, Creating Trackers in Excel and monitoring these/Conditional Formatting.