Clinical Evaluation Specialist (m/f)
permanent position, homebased
Start date: immediately
Language: German and English required
Do you have experience within the clinical field and did you work with Medical Devices previously? Would you like to work with cutting edge innovation and state of the art technologies?
Due to continuing strategic growth within the Medical Devices business, my client is currently looking for a Clinical Evaluation Specialists (m/f).
Take this excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe. This role offers real diversity and variety carrying out detailed assessments of clinical data to ensure that Active Implantable Medical Devices (AIMD) meet the safety and performance requirements of the regulations including.
Your role as Clinical Evaluation Specialist (m/f):
- In this role you'll be compiling Clinical Evaluation Assessment Reports (CEAR's), managing the submission of CEAR's and supporting documentation to the EU Commission for clinical evaluation consultatio
- Within a team of medical device professionals you will determine the clinical impact of design changes and determine the level of clinical assessment required
- Also in your responsibility is to ensure that the clinical aspects of Design Dossier Reviews and Technical File Reviews are completed on time
- You'll also work with our Internal Clinicians to ensure that the relevant External Clinical Experts and Clinical Statisticians are engaged in the clinical assessment process
- You will ensure that the clinical requirements of the Active Implantable Medical Devices Directive and Medical Device Regulations are being met
- To be successful in this role you'll need to demonstrate a thorough knowledge of the design, development and implementation of clinical trials
- You should have a working knowledge all required regulations such as the ISO 14155 Clinical investigation for medical devices for human subjects - GMP, etc.
- You have a proven track record of experiences with Risk management and in particular the assessment of clinical data to support a risk / benefit argument as well as involvement in clinical trials, including providing clinical support to physicians and surgeons and a BSc, MSC, or PhD degree in a discipline relevant to medical device manufacture and use (e.g. engineering, medical, nursing etc.), or equivalent qualification
- The role also requires you to have extensive experience with Active Implantable Medical Devices
What my client offers:
- My client offers a highly competitive starting salary plus bonus
- employees are offered a wide range of flexible benefits
- you will be working with experts in your field with the best possible opportunity to deliver an excellent service and progress your career
- you will get a comprehensive induction into the role and will be supported in a continuous professional development programme
Did I get your attention and you are interested in the position?
I'm looking forward to your application. For more details on the position and the company please contact me via phone 0049 89 5519 7750 or send me an Email at r.nestmann[at]progressive.de
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