Bedrijfsomschrijving
About the company:
Our clients are global leaders in health technology and pharma.
Why YACHT ?
Because of challenging positions at leading (biotech) companies, a large network and development opportunities! These are the advantages of working via YACHT.
With us, you will get all the space to grow further. Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.
Through us, you will get access to a network of professionals and companies that are happy to share their knowledge and opportunities with you.
The world is changing and going through transformation at a rapid pace. The labor market is constantly making new demands on professionals. YACHT knows better than any other company how the labor market is developing, and can ensure that you are prepared for these changes. Now and in the future.
We will help you to keep developing yourself within challenging projects we offer at leading organizations. At the same time, you will make a difference for our clients by realizing improvement of their products and processes. That requires quality work of professionals who are able to take on the real challenges.
Functieomschrijving Job description:
Yacht is looking for a specialist in Regulatory Compliance with strong knowledge and experience with Medical Device standards and regulations, to work at the large company in the Netherlands.
In this role, you will be responsible for providing support in the following activities:
- Development of the Standards and Compliance plan
- Creation the project deliverables related to Norm Compliance responsibilities.
- Definition of standards and regulations for products under development, such as, IEC 62304, IEC 60601-1 series, IEC 62366, and EU MDR.
- The implementation and verification of all specified legal requirements
- Support testers with the interpretation and testing of standards and regulations concerning the technical design of image-guided therapy (IGT) products.
- Technical support to the Regulatory Affairs department with for the preparation of submissions
Functie-eisen Job requirements
- Bachelor's or Master's Degree in Engineering, Biomedical Engineering, Regulatory Affairs, or a related field
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- Knowledge and experience with Medical Device standards and regulations (such as IEC 60601-1 series, IEC 62304, IEC 62366, and EU MDR).
- Demonstrated experience in developing and managing standards and compliance plans
- Experience in supporting design and testing teams with interpreting and applying standards and regulations to technical designs.
- Experience providing technical support for regulatory submissions to bodies such as the FDA, EU regulatory authorities, and other relevant agencies
Arbeidsvoorwaarden Terms of employment
If you meet these criteria and are interested to be presented to our customers, please introduce yourself and send us your CV and (short) cover letter!
Based on the incoming applications and availability of suitable positions, we will select and invite candidates to meet us and to explore career opportunities. Please note that we may not have a specific vacancy that matches your profile at that time, but we may receive it again in the (near) future.
We offer challenging positions which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
This concerns a secondment contract. We have an open position for 1 year with possibility of extension and a permanent contract at the company. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefit package in line with your seniority and the seniority of the position
(with max. 5400 euro per month based on 40 h per week).
