QA/RA Consultant

We are now looking for a QA/RA consultant to join our growing team in Gothenburg.
Who are you?
To succeed in this role we think you will have several years of QA/RA experience within medical device as well as knowledge in setting up and maintaining Quality Management Systems (QMS) and updating technical files to fulfil the requirements of relevant regulations, standards and guidelines including MDR, MDD, GMP, ISO 13485, ISO 14971. A good understanding of the European medical device directives and FDA guidelines for medical devices are required.
To thrive at PharmaRelations and with our clients, we believe that you are a non-prestigious person who both has the eagerness to learn as well as to share your experiences. We believe you enjoy working together with the team, building strategies and new relationships. At the same time, you have a strong drive of your own and like to structure and influence your own work.
Required Education / Knowledge / Experience
· Minimum 3 years of experience working with within Life Science and Medical Device
· Experience from quality assurance and regulatory affairs concerning medical device
· Deep knowledge in relevant regulations as MDR, MDD, GMP
· Excellent communication skills
· Educational background, master’s degree in science or BSc with extensive work experience
· Language skills: Swedish (excellent), English (fluent)