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Evidence Evaluation Specialist IV

Location: Andover, Massachusetts
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Evidence Evaluation Specialist IV
12+ month contract 
Andover, MA 
 (MDR experience, CER experience, Ortho/Trauma preferred but not required) Extension possible, Temp to full time possible.

The role of an Evidence Evaluation Specialist is a highly specialized role requiring a unique blend of Medical writing experience, clinical and device knowledge, scientific expertise and regulatory understanding. A suite of highly technical documentation is required for the successful registration of all medical devices being placed on the market in Europe and other countries. The importance of these attributes & qualifications for personnel authoring these materials are explicitly called out within the regulation and are monitored by Notified Bodies during audits. Completion of a Clinical evaluation draws on each of these qualities to demonstrate that the clinical data supports the ongoing safety and performance of devices. As an Evidence Evaluation Specialist these attributes will continue to be matured with increased autonomy.

Role Overview:
The purpose of this role is to use medical writing and literature review experience to generate clinical documentation (incl. CER’s, CEP’s etc.) in accordance with the appropriate regulatory standards to ensure continued CE registration of Smith+Nephew products. This is achieved by demonstrating a device has sufficient clinical evidence to confirm its performance and safety. The role of the Evidence Evaluation Specialist’s also encompasses production of various documents related to the clinical evidence including the clinical evaluation report (CER), the clinical evaluation plan (CEP), summary of safety and clinical performance (SSCP), evidence gap analysis and benefit risk assessments. Based on these processes and their clinical knowledge they will support strategic business decisions. Such decisions will ensure that full regulatory conformity of a device can be demonstrated and vitally whether a product should be placed on the market.

The key requirements of the role include:-

Maintain a good understanding of current clinical practice.
Remaining abreast of the device area such as technological developments and device usage within the clinical setting.
Remain up to date with current treatment pathways and the priorities for device users.
Maintain understanding of common treatment alternatives and similar devices.
Remain informed of current medical concepts and terminology.
Maintain a thorough understanding of the regulation including;
MDD 93/42/EEC
MEDDEV 2.7/1 Rev 4
EU MDR 2017/745
MDCG 2020-5
MDCG 2020-6
Understand different routes to demonstrate conformity and apply appropriately.
Act as subject matter expert in relevant disciplines to support and guide wider business.
Utilize knowledge of clinical field to collaborate with other teams regarding post-market clinical activities to facilitate assessment of conformity.
Provide input in design and risk documentation based on knowledge of clinical evidence for specific device and wider scientific area.
Act as subject matter expert during audits/submissions to respond to Reviewer’s questions and non-conformity findings.

Produce of clinical documentation including, but not limited to, the Clinical Evaluation Plan, Clinical Evaluation Report and Summary of Safety & Clinical Performance.
Complete extensive searches of external literature databases to ensure all relevant data is identified through:-
Development, review and adapting database search strings.
Conduct systematic reviews in a repeatable and traceable manner.
Generate and maintain reference databases
Reviewing scientific journal articles and extracting relevant information.
Apply understanding of research methodology and biostatistics to appraise quality and relevance of data.
Identify, appraise and analyze data from relevant sources (pre-clinical testing, internal clinical investigations, post-market surveillance, risk, registries and post market clinical activities) to assess a devices benefit/risk profile.
Summarize safety and performance outcomes from clinical studies and other sources.
Assimilate and discuss key scientific themes identified through literature searches.
Effectively communicate scientific information to the target audiences (e.g. healthcare professionals, Notified Bodies, general public etc.)

Work with team to determine device's conformity with regulation and suitability to be placed on the market by establishing level of sufficient data to confirm safety and performance of device to determine conformity.
Based on conclusions of Clinical processes initiate and drive required changes to business processes and/or information materials supplied by the manufacturer.
Attend meetings to provide background on clinical routes of conformity and confirm availability of current data to support for New Product Development projects.
Work with internal teams to gain cross-functional inputs into authored documents.
Facilitate approval of Evidence Evaluation documentation.
Communicate and interact effectively with multi-functional teams to acquire information and facilitate required actions.
Interprets internal and external business challenges to drive best practice

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