KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Product Specialist Medical Device/IVD will be varied however the key duties and responsibilities are as follows:
1. You will conduct desk based and on site reviews of technical files under the relevant EU Medical Devices Directives/Regulations, you will maintain a high standard of service delivery throughout.
2. It will be your responsibility to project manage the technical reviews of clients maximising efficiency and client satisfaction while also ensuring compliance to regulatory guidelines and in accordance with an allocated budget/time-frame.
3. The Product Specialist is responsible for maintaining current and specific Subject Matter Expertise in their specialist area to as to continue their professional development and provide technical support/training to clients and colleagues. You will develop your understanding of clinical evaluation requirements as it relates to Class III/Annex II List A IVD Medical Devices.
4. The Product Specialist will report to the Senior Management Team to assist in the management and planning of operations ensuring the clients maintain regulatory compliance at all times. They will comply with internal standards and codes of conduct and enhance the reputation of the notified body.
To be successful in your application to this exciting opportunity as the Product Specialist Medical Device/IVD we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific/Engineering discipline with proven industry experience of conducting audits in the Medical Device Industry.
2. Proven industry experience in the Clinical Development/Manufacture of High Risk Invasive/IVD Medical Devices, in a role ensuring compliance or conducting inspections.
3. A working knowledge and practical experience with relevant Medical Device Regulations according to the audit or technical review being undertaken. You must have technical expertise in a specialist area e.g Cardiovascular/Orthapedic or Blood Group IVD testing.
Key Words: Medical Device | Class III Device | Notified Body | 98/79/EC | 93/42/EEC | IVD | In Vitro Diagnostics | Technical Files | Clinical Evaluations | High Risk Medical Devices | List A Devices | Compliance | Regulatory Compliance | Audit | Clinical Trial Reports |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
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