/Quality & Regulatory Engineer(s) – Medical Devices & Clinical Studies

Quality & Regulatory Engineer(s) – Medical Devices & Clinical Studies

Research & development - Wageningen | More than two weeks ago

Ensure quality and compliance to good clinical practice, data privacy, and medical device regulations, within a dynamic R&D environment.

Quality & Regulatory Engineer(s) – Medical Devices & Clinical Studies

What you will do

We need you as a Quality & Regulatory Engineer to (partly) set up and manage a quality management system, including coaching, and supporting project teams to work with the procedures. Next to that, your task is to make sure research/clinical studies are done conform to standard regulations for Good Clinical Practice, data privacy and medical device regulations. The creation of internal standard operating procedures for studies with human subjects may be part of the job. As a Quality & Regulatory Engineer you will have an important role in the ‘ingestible sensor project’ in preparation for human studies.
We are looking for two candidates that can team up for quality and regulatory tasks and with multidisciplinary project teams of biomedical researchers, electronic engineers, biochemical engineers, and data scientists.

Other tasks include:

  • Define, maintain, and roll out internal procedures for medical device development and use in clinical studies (in line with ISO 13485, IEC 62304 and MDR).
  • Give guidance and support to the team with respect to privacy and processing of personal data.
  • Work with the Data Protection Officer (DPO) of imec to ensure that OnePlanet Research Center complies with the GDPR and internal data protection and health care compliance regulations.
  • Build up the knowledge of the interplay between the Clinical Trials Regulation and the General Data Protection Regulation (GDPR).
  • Take the lead in managing and reporting the quality and regulatory compliance for OnePlanet and its projects to management.
  • Additional tasks, depending on the background of the candidate, may include test set up definition, engineering, or research tasks.

What we do for you

We offer a challenging and international environment at the forefront of technology, in an international network of renowned industrial customers. This is your opportunity to bring new technologies to the market that will have an impact on tomorrow’s society. 

OnePlanet Research Center is a multidisciplinary collaboration agreement between Wageningen University & Research (WUR), Radboud University, Radboudumc and imec. Imec The Netherlands, as an employer of choice, offers you an attractive compensation and benefits package including a 100% employer paid pension plan and flexible working hours. Furthermore, imec-NL offers a wide range of training possibilities. 
 
At the same time OnePlanet is a new collaboration of 3 renowned and globally respected research institutes/universities. By joining the OnePlanet team, you will be part of a team of world changers; disruptive innovators and practical thinkers. Here, your ideas will have an impact on our future lives. 

Who you are

  • Bachelor's or Master's degree in the technical engineering or biomedical field.
  • Work experience in regulatory Affairs and/or Quality Assurance in relation to the development of medical (research) devices and use in clinical studies.
  • Experience with Clinical Trials Regulation, Medical device directive and General Data Protection Regulation (GDPR).
  • Solid understanding of the Ethics Committee/Institutional Review Board activities.
  • For this position proficiency in the Dutch language is required because of the written language of the regulations, Dutch language skills are also required for clinical studies. We also ask for excellent English language skills.
  • Able to deal with ambiguity. You see changes as an opportunity to learn and grow.
  • A quick learner interested in acquiring new skills and competencies.
  • Hands-on attitude, which means taking initiative, thinking pro-actively, having a flexible attitude and solving problems.

Interested

Does this position sound like an interesting next step in your career at imec? Don’t hesitate to submit your application by clicking on ‘APPLY NOW’.
Should you have more questions about the job and about the recruitment process, you can contact Perine Doreleijers, Talent Acquisition Specialist. She will be happy to assist you. You can reach Perine on +31(0)6 48 86 12 56 or by email at perine.doreleijers.ext@imec.nl. If you wish to apply, then please submit your full resume and a cover letter.