Senior Clinical Affairs Analyst

Location: Bengaluru

We are seeking an experienced  Clinical Writer  to join our team in Hyderabad. In this position, you will independently contribute to the development of initial and updated Clinical Evaluation Reports (CERs) that support the applicable regulatory submission requirements for our medical device products.
We are looking for a highly experienced Clinical Analyst professional with a relevant medical/life-science qualification and knowledge or direct clinical experience in the use of medical devices in a clinical setting. Your experience should be current or recent (preferably within the past two years) to ensure familiarity with the rapidly evolving regulatory landscape, device functionalities, and therapy areas.

Key Responsibilities    Independently contribute to the development of initial and updated  Clinical Evaluation Reports (CERs) .
Ensure CERs support applicable regulatory submission requirements for medical device products.
Apply relevant medical/life-science knowledge and direct clinical experience with devices in a clinical setting to content development.
Write and review scientific, medical/clinical, and technical content for regulatory documents.
Qualifications & Experience     Preferred Education :
Master's degree in a life science or biomedical engineering discipline, or equivalent regulatory/writing experience.
The expected experience is  7-8 years , with a minimum of  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.

Experience with writing CERs that conform to  MEDDEV 2.7/1  is a strong plus.
A minimum of  3-4 years of medical writing/reviewing experience  is essential.
Experience should be current or recent (preferably within the past two years).
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 assess and provide device-appropriate clinical evaluation data for registrations.