Reports to: RA/QA manager
Location: HQ Mechelen, Belgium
The role holder is responsible for ensuring that Nipro Medical Europe (NME) meets all requirements of the current European Medical Devices Directive and Regulation and/or any other regulatory aspects connected to Nipro Medical Europe products and/or organization.
- Under the guidance and directions of the RAQA manager, to achieve agreed functional and personal objectives within area of responsibility.
- Has end-responsibility over the Technical Files kept at NME and at NME factories (NRS and NPW)
- Effectively manages, in line with procedures, all regulatory documentation connected with medical devices; records, document preparation, document approvals and document release.
- Co-ordinates the detailed preparation and use of product specification in marketing material. Working closely with the marketing and sales team.
- Supervise the PVNC/VNC process.
- Monitors and communicates about changes in the Regulatory field affecting NME products.
- Provide Regulatory support to NME customers, Mainly OEM customers.
- Participates to teams working on improvements to the quality system and continuous improvement projects.
- To produce and review SOPs relating to the Regulatory Affairs function.
- Manages, guides and coaches the RA/QA assistant.
- Demonstrates flexibility and mobility in order to optimize contact with the different business units and entities
- The role holder will perform all tasks in accordance with JSOX and ISO quality requirements and taking Nipro values into account.
Education and Experience
- Life Sciences related education is a plus.
- Minimum of 3 years ‘experience, this experience should include a proven understanding of the regulatory process (Technical File) and experience in leading a project to a successful completion.
- Knowledge of EU and Belgium registration.
- Knowledge of ISO 13485 : 2016 is a plus.
- Excellent organization skills.
- Ability to work well within a team.
- Process orientated with good attention to detail.
- Effective oral and written English communication skills.
- Willingness to travel (Max 20%)
Please send us your latest CV and motivational letter to:
Nipro Europe Group Companies
attn. Human Resources Department
or use the application form from the careers page