As MR Complaint Specialist you are responsible for identifying product complaints per regulatory definition and for taking assigned investigations from evaluation to closure in accordance with internal and external (FDA, Canadian and European) regulatory requirements. In this role you will work closely together with colleagues from different departments, like; Field Service Engineers, Clinical Support, Field Specialists, Technical Specialists and Engineering.
Your key responsibilities will include:
- Getting the basic facts related to a reported issue, following up if necessary and completing investigations in a timely manner. If necessary you will ensure timely submission of problem reports to government agencies.
- Investigating complex clinical and technical issues and identifying potential safety problems. If necessary getting the appropriate product specialist or Engineer involved to resolve the problem or provide root cause.
- Presenting the data in a clear and concise manner in accordance with Standard Operating Procedures into the complaint record.
- Initiate and participate in post market risk assessments consistent with applicable regulatory standards and industry practices.
- Compiling and presenting management information based on customer feedback data.
Your Profile:
To be successful in this role you have;
- Bachelor or Master degree in the technical field
- Some years of experience related to product quality and handling internal and external complaints. You are able to understand domestic and international regulations as well as internal operating procedures.
- Good communications skills and you are fluent in English, both in words and in writing.
- You are a team player, results driven, pro-active and you are able to work under pressure.
