This is a remote, home-based role suitable for a medical doctor who is seeking to move into the medical device industry. There will be 25% travel in this role – 1 week / month, typically.
As a member of the Global Clinical Team, conduct clinical reviews on Medical Device documentation submitted to our client for the purpose of initial and renewal of CE Marking the device(s) in Europe. Review and approve clinical evaluations performed by external clinical experts.
Ensuring clinical reviews are performed by experts (internal or external) that have the required competencies to plan, conduct and interpret the results of client clinical investigations and reports.
Performing clinical evaluations for which the position has the required competencies and knowledge.
Reviewing/approving clinical evaluations performed by external experts.
Auditing clinical procedures (e.g. clinical evaluation, clinical investigation, clinical monitoring) at customers as part of the audit team.
Reviewing vigilance cases as required and provides expert clinical opinion to the Certification Manager.
Providing clinical and medical training to staff to continually develop their competences in this area.
Support and validate the selection of external clinical experts and ensure appropriate review time calculations are performed.
Perform training to the global team of experts (auditors and internal and external reviewers) to ensure appropriate competency levels are maintained.
Contribute to the development of the clinical review process.
A medical doctor with a comprehensive knowledge and understanding of clinical trials and a broad scope of clinical expertise.
General knowledge of the Technical Dossier review process, the audit process, the knowledge management process, the peer review process, the Certification Management Process.
Comprehensive knowledge and understanding of the clinical evaluation process including the external expert review process and the specific roles tasks and responsibilities of the external clinical experts.
Comprehensive knowledge and understanding of all applicable laws, regulations, standards and guidance documents required to carry out the assigned responsibilities.
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747