Technical Documentation Assessors

Söker nu till en Notified Body, Technical Documentation Reviewers med kunskap inom en eller flera av koderna nedan.
En roll med stor frihet. En roll som kräver kunskap och noggrannhet.

Key purpose of the role:
Primarily, this role has accountability for performing assessments of compliance of client Technical Documentation (TD) against the following requirements;
− Council Directive concerning Medical devices 93/42/EEC
− Medical Device Regulations 2017/745
− ISO9001, ISO13485 and ISO13485 under CMDCAS programme
(The job role is a home-based role. By prior arrangement, the role may involve travel through UK and Internationally to client’s facilities to execute assessments or act as a Technical Expert in an audit team)
Specific Technical Documentation Assessor responsibilities: Technical Documentation Assessment
• Perform pre-assessments of client Technical Documentation to determine suitability to progress the TD for assessment and estimate time required for the TD Assessment
• Perform conformity assessment of EC Technical Documentation according to approved processes and procedures, identifying and documenting non-conformities as necessary
• As part of the conformity assessment, and where approved to do so, review conformity of o Microbiologyandsterilization
o Biocompatibility
o ClinicalData
• Lead and manage the technical assessment team (all assessors involved in the TD review)
• Liaise with the client to address any findings in a timely manner
• Correspond generally with clients as needed in respect of the scheduled assessment activity.
• Raise suspension documentation as needed where findings are not adequately addressed
• Perform quality checks, peer review and/or sign off of other assessor’s assessments prior to
submission of initial report to the client.
• Perform Certification Authority reviews under the guidance and oversight of the Certification
• Document the above assessments and reviews in accordance with the appropriate current local
and global company issued processes and complete them in a timely manner.
• Comply with the relevant Notified Body Quality System processes and procedure at all times

Other Skills
• The role holder has 3 years’ experience in administration roles.
• The role holder has preferably 2+ years’ experience working for a Notified Body or a management
system registrar.
• The role holder has preferable 2+ years’ experience working in the healthcare industry or related
Test Laboratories.
• Fluent in English and Swedish, written and spoken.

For more information about the position, please contact Erik Düring at +46 708 999469 or