Regulatory Specialist

Location: Mansfield, Massachusetts
Posted On: 8/5/2017
Job Code: 7460_CAS_MA_MF
Job Description
Job description:
• Evaluates incoming complaint information and maintains it in the electronic database.
• Determines report ability (MDR/AE) of complaints to FDA and other international regulatory agencies.
• Works closely with customers and sales representatives to respond to complaint reports.
• Closely monitors quality, completeness and timeliness of complaint investigations and files.
• Reviews, analyzes on complaint data and escalate issue and trends to Management and other departments as needed.
• Works with cross functional teams to ensure proper communication and evaluation/investigation of customer issues.
• Participates in team decision making and displays team problem solving/communication skills.
• Complies with all health, safety and environmental policies.


Do you have these experiences or skills?
• BS in clinical/medical, engineering or science disciplines is preferred
• 0-2 years experience in an quality or regulatory environment
• Strong Customer Service skills
• Data analysis
• Basic understandings of industry practices and standard
• Proficient with MS Office
• Solid verbal and written communicator
Category:Non-IT  code:new
Job Requirements
regulatory ,MDR/AE, Medcial device report,complaint

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Contact Details
Sparsh Patel
E-mail Address