Do you have Quality and Regulatory Affairs experience in the field of development and certification of medical products? And would you like to work in a dynamic environment with a wide variety of products? Then we are looking for you!
Each one of our companies differentiates itself in its own domain with unique expertise and skills. This way they help customers improve their performance and achieve more. On the basis of their passion for technology our companies are able to combine forces. By sharing knowledge and working together we increase our social impact. Demcon life sciences & health is a multidisciplinary development and engineering partner for mechatronic challenges, from concept to realization, in the field of life sciences & health.
What are you going to do?
The senior QA/RA specialist at Demcon is a challenging position with very diverse work. You work closely with all disciplines within Demcon, but also have contact with external parties. We are looking for someone with a few years of experience in the RA profession in the field of development and certification of medical products.
As a senior QA/RA specialist you will be part of the quality team at Demcon’s Life Science and Health company in Best. The senior QA/RA specialist is part of the multidisciplinary project team. Within this team you lead the RA activities in the area of medical products. You define the regulatory strategy, in close collaboration with our customers. You advise the development team with respect to certification of medical products.
Your challenge is to ensure product safety and proper practices in line with our quality system. Within the development projects you are responsible for product safety and to determine which standards and regulations apply and coordinate these matters with the customer. For certification you bring the technical file in order.
What do you bring to the table?
· Master’s degree in biomedical technology, engineering medicine, health sciences or a technical education.
· At least 5 years of experience in the RA profession in the field of development and certification of medical products
· You are a team player, who can communicate and interact well at various levels both towards project team and client.
What do we offer you?
At Demcon we value a nice workplace. For example, we have good coffee and there is free fresh fruit waiting for you every week. There is also a lot of personal attention, and we discourage overtime because we know how important home is.
Furthermore, you can count on, among other things:
· A good, market-based salary
· 31 days off and 8% vacation allowance
· A good pension plan at Zwitserleven
· The opportunity to follow training and courses through the Demcon Academy so you can further develop your knowledge
· A laptop and telephone from work
· Bicycle plan
· Active personnel association (monthly activities such as drinks and an annual Demcon weekend) and annual sporting events
Do you have any questions about this position?
Have we aroused your interest for this assignment? Then we look forward to receiving your cv. You can apply via the application button.
Acquisition based on this advertisement is not appreciated.
Does this vacancy appeal to you and are you curious about the application process? This goes as follows:
You have applied! We will discuss it internally and respond as soon as possible.
2. Phone call
We got acquainted briefly and want to get to know each other better.
3. First call
See if there is a match from both sides and if the expectations are correct.
4. Second call
We investigate a possible collaboration more closely.
We both see the match! Let’s make you a suitable proposal.
Your response to the offer is positive. We are going to finalize the collaboration!