Senior Clinical Affairs Analyst

Position Summary :

We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CER's that support the applicable regulatory submission requirements for the medical device products.

An experienced Clinical Analyst professional has relevant medical / life-science qualification and knowledge / direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 7 - 8 years with a minimum of 3 – 4 years of CER writing experience is essential. A minimum of 3 – 4 years of medical writing / reviewing experience is needed. 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 Education : Masters' degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory / writing experience

Preferred Experience :

• The expected experience is 7 – 8 years with minimum 3 – 4 years of CER writing and reviewing experience as per EU MDR (European Union Medical Device Regulation (EU) 2017 / 745). Significant experience writing scientific, medical / clinical, and technical content. Also, a plus would be experience with writing CERs that conform to MEDDEV 2.7 / 1.
• Knowledge in the therapeutic area – specifically in the field of diagnostic radiology, interventional radiology and radiation oncology
• 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.

Skills Required

Medical Writing