- Project engineer
Quality and Regulatory Affairs (QARA) Consultant
Verhaert - Life Sciences
Are you dynamic, meticulous and entrepreneurial? Do you get energy from thinking along with clients? Do you want to contribute to the development of innovative healthcare products having a high impact on people’s health? Does the evolution towards digital health appeal to you? …then you should keep on reading and join our dynamic team.
Verhaert is looking for a motivated Quality Assurance and Regulatory Affairs (QA/RA) consultant to support our project teams in the development of innovative life science products. You will act as a sparring partner within the company, providing expert regulatory and quality input to our project teams of designers and engineers, thereby helping our clients get to market with their innovative medical and in-vitro diagnostic devices. As QA/RA consultant you will also help improving our Quality Management System.
- Build up and maintain expert current knowledge of European and US regulations, legislations, best practices and guidelines related to QA/RA
- Support project teams by providing expert input and know-how on regulatory compliance and standards. This includes the development of products according to Medical Device and IVD legislations (e.g. standards IEC 60601, IEC 61010, ISO14971) and industrial and consumer products (e.g. standards ISO11161, IEC60335, IEC61000).
- Support core quality systems including root cause analysis, CAPA, non-conformance analysis, change control, and risk management, as well as control of documentation and records.
- Support in writing technical documentation for regulatory submissions
- Support in writing subsidy application files
- Work according to the Verhaert Quality Management System (ISO13485)
- Support training of colleagues in numerous QA/RA domains
- Master’s in biomedical engineering, information technology or other (scientific) discipline relevant to medical devices and IVDs
- Professional experience in Quality and/or Regulatory Affairs
- Ability to interpret and apply regulations and compliance concepts.
- Strong analytical and problem-solving skills and able to work autonomously
- Eager to learn and open positive mindset
- Customer-centric thinking and effective communication skills, both written and oral
- Detail oriented
- Team player
- Proficiency in English and Dutch
- Computer literate (MS Office)
Why Verhaert Life Sciences?
- A challenging project-driven job with responsibilities
- Central position in a growing company
- Work on the design and development of innovative products and solutions, from concept to production
- Great team of enthusiastic colleagues.
- Coaching on the job and continuous learning opportunities