Job Description

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Position Summary:

We are looking for a Clinical Expert who is responsible for clinical evaluation and PMCF activities; collaboration with CLM owners/Risk manager/PMS manager.

Qualification:

\xc2\xb7 MBBS or equivalent Medical degree; specialization in Radiology is preferred.

\xc2\xb7 Knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 3-4 years with a minimum of 1 \xe2\x80\x93 2 years of CER writing experience is essential. A minimum of 1 \xe2\x80\x93 2 years of medical writing/reviewing experience is needed.

\xc2\xb7 Knowledge on Medical devices regulations

\xc2\xb7 The experience is expected to be current or recent (preferably within the past two years), to provide confidence in their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities, and the therapy area.

Preferred Experience:

1. Significant experience writing scientific, medical/clinical, and technical content.

2. Knowledge in the therapeutic area \xe2\x80\x93 specifically in the field of diagnostic radiology, interventional radiology and radiation oncology

3. Familiarity with various country specific standards and regulations for medical devices to be able to assess and provide device appropriate clinical evaluation data for registrations.

Duties and Responsibilities

1. Collaborate with the project/program stakeholders for product knowledge and information to develop quality content for the CER\xe2\x80\x99s and within the required timelines.

2. Able to work in cross functional teams with strong communication, presentation & interpersonal skills

3. Analytical thinking skills with strong demonstration of scientific writing and verbal communication.

4. Manages projects in the context with full responsibility for the results and drives the development of clinical evaluation report, Pre-CER, CLP and/or services that are on time and meets the quality, regulatory and customer requirements.

5. Mentoring and coaching the team on technical topics

6. Responsible to implement process changes as per the new/updated regulatory requirements

7. Defining clinical development activities/ PMCF activities

8. participating in the assessment of clinical benefit-risk profile of the clinically relevant risks identified in the risk management upon request of the risk manager

9. assessing and aligning the device\xe2\x80\x99s clinical benefit-risk profile between the clinical evaluation and risk management jointly with the risk manager

10. supporting post-market surveillance manager on the PSUR/PMS reporting by providing summary of the relevant clinical evaluation report contents, and in planning/coordinating device\xe2\x80\x99s PMS activities with the device\xe2\x80\x99s clinical evaluation and PMCF.

Siemens