Our client is a leading Notified Body in Europe for medical device accreditation services, providing medical services to customers around the globe. They are entitled to carry out tasks related to conformity assessment of medical devices and in vitro diagnostic products with EU Regulations before such products are placed on the market.
As part of their continued growth, they are looking to recruit a technical and experienced Medical Device Assessor / Auditor in Europe. The successful candidate will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, MDD/IVDD, MDR/IVDR and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
- Performing onsite Audits at manufacturer premises (approximately 50% travel required for this role).
- Auditing Quality Management Systems in accordance with the requirements of the MDR or IVDR, and other standards including ISO 13485, ISO 9001 and MDSAP.
- Reviewing Technical Documentation as part of product conformity assessments of Medical Devices or IVD Devices in accordance with the MDR 2017/745 or IVDR 2017/746.
- Preparing reports included deficiency reports in case of non-conformities according to the requirements of the ISO 13485, ISO 9001, MDR/IVDR and MDSAP standards.
- Delivering high-quality, consistent and concise services within clear timeframes.
- Commitment to training and intensive familiarisation with the ISO 13485, ISO 9001, MDR/IVDR and MDSAP standards.
- University degree in scientific or engineering studies, (biology, biochemistry, biotechnology, biomedical engineering, etc.) or comparable field of study.
- Minimum four years of professional experience in the manufacturing environment of the health care sector, ideally with a direct manufacturer of medical devices.
- Technical product knowledge in the field of medical technology and specific medical devices product groups.
- Fluency in written and spoken English.
- Sound knowledge of quality management or regulatory affairs according to ISO 13485 and ISO 9001.
- Strong knowledge of the MDR or IVDR requirements is a significant advantage.
- Excellent organisational and professional communication skills.
- Ability to work in a team, pronounced customer orientation and good self-organization.
- Certifications and professional experience in auditing or quality management are an advantage.
- Experience in a customer facing role is an advantage.
- Curiosity and willingness to learn.