FUJIFILM Manufacturing Europe B.V. has a key position for a Regulatory Affairs / Quality Assurance Specialist in our R&D facility in Tilburg, The Netherlands.
As a Regulatory Affairs / Quality Assurance Specialist you will compile and prepare regulatory submissions for medical device registration in accordance with GMP, ICH Q7, ISO 13485, MDR 2017/745, ISO 14971 and related country regulations. Furthermore, you will interact with other departments to assure regulatory compliance from the start of design and development up to and after release of the product to the market. Also, you will align and discuss the regulatory strategy with the Japanese headquarters.
In addition, you will take part in managing, maintaining and improving the Quality Management System, ISO certification, internal and external auditing, training of coworkers and related quality tasks (batch release, evaluation of changes, deviations, production issues etc).
- Master's degree in Chemistry, Biochemistry, Life Sciences or comparable;
- At least 4-5 years’ experience in Regulatory Affairs / Quality Assurance in a medical device or pharmaceutical company;
- Knowledge and understanding of European and US regulations for medical devices, ISO 13485, ISO 14971, ICH guidelines, and other relevant guidelines;
- Experience or knowledge related to clinical investigations for medical devices and subsequent submission to notified bodies;
- Willingness to travel abroad (e.g. Japan). Expected frequency up to 2 times a year;
- The function will be a part-time function of 20-24 hours a week. Working schedule can be discussed.
For non-native speakers we require basic knowledge of the Dutch language as well as the willingness to further improve.
We are looking for
An independent and critical mind who easily interacts with partners and colleagues in, and outside Fujifilm Tilburg (e.g. Fujifilm Japan). You are an expert in your field of work. You feel at ease taking this expert role and you are able to convince others. You like to digest a large amount of information and your analytical skills are excellent. You are able to communicate on all levels and your interpersonal sensitivity skills are well-developed.
Where will you be working
FUJIFILM Manufacturing Europe B.V. Is Fujifilm's largest production base outside Japan. Here, with about 800 employees, we are responsible for the production of photo paper, offset plates and membranes. At this moment a third manufacturing facility is being built for manufacturing of cell culture media. In addition, part of the European headquarters is located in Tilburg. This company is responsible for purchasing, finance, IT, logistics and customs. At the Tilburg Research Laboratory we are continuously developing new technologies and products.
The section BioScience and Engineering Laboratory – EU (BSEL-EU) within the Tilburg Research Laboratory is responsible for Research and Development of our recombinant peptide based products and their application in medical devices.
At FUJIFILM Manufacturing Europe B.V., we know that our people are central to our success. We want our employees to feel at home in the company. We offer compensation & benefits that are competitive in the market and seek for deployment of talent by investing in studies & training. Securing the employability of our employees is key within our human resources policy.
We furthermore offer:
- A 20-24 hour working week and the opportunity for flexible working hours;
- An above average salary depending on educational background and experience;
- A good bonus scheme;
- 27 holidays (at full-time employment);
- 12,5 LTR-days (at full-time employment);
- A commuter allowance;
- Excellent pension regulation;
- Discount on health insurance;
- Good training and development opportunities;
- Other secondary working conditions like participation in the cycling plan or discount on trips.
You will be located in Tilburg.