Regulatory Affairs Officer
il y a 1 semaine
As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical Europe, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.”
To accommodate our growth at Nipro Medical Europe (NME), we are looking for a Regulatory Affairs Officer based at our European HQ in Mechelen.
**About the Role**:
As RA Officer you will prepare and update the Technical Documentation together with the local Technical and RAQA Teams, during its lifecycle. Above that, you will give support to our manufacturing plants in Germany and Spain about Regulatory Affairs. You manage communications, prepare and coordinate legalization of documentation needed for registrations in the name of the Manufacturing sites (NRS, NPW, MTN) in Europe.
**What You'll Do**:
1. The majority of your time you will spend on Technical Documentation Life Cycle Management (60%)
- Prepare and update the Technical Files together with the local Technical and RAQA Teams.
- Design and Develop documentation updates (validation, verification, transfer, Design and Verification Matrix).
- Update the Risk Management Files together with the local Technical and RAQA Teams.
- Support the plants with the Post Market Surveillance (PMS) obligations:
- Elaboration of Periodic Safety Update Report (PSUR) for each device family.
- PMS plan
- PMS reports including surveillance analysis
- To participate in Quality Management System audits from the different Notified Bodies for the NME manufacturing plants with regards to the Technical Documentation.
2. 30% of your time you will act as Registration Officer for the NME factories
- Manage communications between tenders and plants related to registrations for the NME manufacturing site.
- Prepare documentation needed for registrations for Rest of the World and EMEA in the name of the plants.
- Coordinate legalization of the different documents needed for registrations for the NME manufacturing site.
3. You give Quality Assurance Support
- Follow up and centralize Environmental documentation of manufacturers (Reach, CLP, RoHs)
- Follow up and review Quality Agreements with third parties
- Support the different plants on the strategy for regulatory compliance, helping to update and review the list of applicable standards according to the stablished frequency.
**What You'll Need**:
- You hold a Master degree in a scientific/medical area (chemistry, biomedical sciences, ) or you have equivalent experience in a similar job.
- ISO 13485, MDR and MDD doesn’t have any secrets to you.
- You enjoyed working with Technical files through the whole Life Cycle for several years and you want more from that.
- You feel very comfortable in an English speaking environment.
- You are ready to pack your suitcases on a regular basis to visit our plants in Germany and Spain.
- Connecting with your colleagues and sharing information adds joy to your job.
- Eventhough you have a critical eye, you are positive minded. No challenge is too big for you.
- You are dynamic, flexible and solution oriented.
- We will support you but not hold your hand, you love this independence.
- You show sense of responsibility and always keep Nipro’s interest in mind.
**What We'll Offer**:
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