Complaint and Post Market Surveillance Manager EMEA
For the European HQ of a medical device company in Mechelen, we are urgently looking for a Complaint and Post Market Surveillance Manager EMEA. Do you have minimum 5 years of experience in quality systems, complaint, or post market surveillance within a medical device company? Do you like to take ownership and you are solution oriented?
Please contact Luc Decat to find out more about this great opportunity!
In this position you will be responsible for managing the Complaint Management Team and the full process. This team represents the customer facing department in charge for managing the customer experience through feedback on the company’s products and services.
Together with your team you will be responsible for:
the complaint lifecycle management,
monitoring quality throughout the complaint process,
working with Legal Manufacturers to drive resolution to customer complaints,
regulatory reporting and facilitation continuous improvement driven by complaint data, trending and analyses.
- Supervise the complaints handling process and provides trend analyses to RAQA management
- Effectively manages incident reporting to the Competent Authorities in collaboration with the respective legal Manufacturers.
- Responsible for highlighting any potential reportable events to RA/QA management as soon as possible
- Effectively manages the goods return procedure in closed collaboration with Operation team
- Participates to teams working on improvements to the quality system and continuous improvement projects particularly regarding Complaint handling system and Vigilance
- Lead a team of 2 complaint officers
- Perform all tasks in accordance with ISO and JSOX requirements and taking Nipro values into account
- Minimum 5 years of experience in a quality system or complaint or post market surveillance role within a medical device company.
- Knowledge of ISO 13485 requirements regarding complaint handling and post market surveillance requirement and of MEDDEV 2.12-1 is a must.
- Knowledge of Medical Device Regulation (EU) 2017/745.
- Fluent in English, any other language is a plus.
- Taking & getting ownership is important to you.
- Being well organized, structured and strong in setting priorities.
- Positive (team-) spirit and great flexibility.
- You are a good communicator and know the art of inspiring and motivating colleagues.
- A great mix of planning & hands on execution. You get energized by delivering results!