Description
Medical Devices are some of the most regulated products in the world. This role is part of the Medical Notified Body Team. Working with limited supervision, it will be to independently review the outputs of technical file/design dossier assessments and the output of quality management system audits under ISO13485 for both active and non-active medical devices.Within the framework of our highly regulated Notified Body the incumbent will: -
- Performing project planning and approving of plans which includes scoping technical file sampling rates and quality management system auditing requirements
- Provide an independent and impartial review of assessment outputs of active and non-active medical devices, including technical file/design dossier assessment outputs and quality management system assessment outputs.
- Ensure that the project plan was executed as originally approved or that changes are duly justified and a rationale provided.
- Participate in development of training materials and the delivery of same to both internal and external assessors.
- Interfaces with the MHRA on an as needed basis e.g. MHRA audits.
- Participate in the development of requirements and assessment methods. Integrates continuous improvement concepts into all aspects of the job.
- Overnight travel (both UK and Overseas) will be required.
Desired Skills and Experience
Job Requirements:
A relevant Degree or Degree equivalent such as HTEC/HNC/HND/City & Guilds
Either some years' experience with the evaluation of Medical Devices preferably within a Notified Body or may have gained extensive experience with the design and/or manufacture of a broad range of Medical Devices, management of the Technical File and having the knowledge and understanding of the constraints of manufacturing in a quality assurance controlled environment to enable assessment of conformity to the following standards;
- Experience with MDD 93/42/EEC with awareness of MDD /EC including MEDDEVS;
- ISO 14155 (Clinical data), ISO 10993 (Biocompatibility), ISO 13485 (Quality Management Systems), IEC 60601 (Conformity assessment); IEC 62304 (Device software) standards; ISO 14971 (Risk Management for Medical Devices);
- Additional experience in Non Active Medical Devices, Analytical Chemistry, Toxicology, Bio-analysis, Microbiology or Pharmacological testing would be useful.
- Auditing experience preferred, ideally with another registration body and within MDD.
- Able to demonstrate Critical Behaviours for Success, to include:
- Excellent verbal and written communication skills.
- Confident, calm and decisive personality
- Strong innovative and analytical skills
- Ability to deal professionally with confrontation
- Fluent English language skills
If you like what you have read and you believe that you would be a good fit for this role, we would like to hear from you. Sthree UK is acting as an Employment Agency in relation to this vacancy.