Siemens Healthcare Life Sciences Clinical Affairs Professional Job
Clinical Affairs Professional Job at Siemens Healthcare
Position Summary:
Siemens Healthcare Private Limited is seeking a highly experienced Clinical Affairs Professional to join our team in Bengaluru, Karnataka, India. In this role, you will be responsible for independently contributing to the development of initial and update(s) of Clinical Evaluation Reports (CERs) that support the regulatory submission requirements for our medical device products.
Job ID: 397034
Company: Siemens Healthcare Private Limited
Organization: Siemens Healthineers
Job Family: Quality Management
Experience Level: Mid-level Professional
Employment Type: Full-time
Work Schedule: Office/Site Only
Contract Type: Permanent
Preferred Qualifications and Experience:
- Minimum of 4-6 years of experience in writing and reviewing Clinical Evaluation Reports (CERs)
- 1-2 years of medical writing/reviewing experience
- Masters’ degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience
- Preferred knowledge and experience in the field of diagnostic radiology, interventional radiology, and radiation oncology
- Familiarity with country-specific standards and regulations for medical devices
Duties and Responsibilities:
- Collaborate with project/program stakeholders to gather product knowledge and develop quality content for the CERs within the required timelines
- Screen and summarize literature for relevant clinical data
- Review literature to understand the clinical problem and current treatment techniques
- Study and report device characteristics and instructions for use
- Evaluate data for similar competitor devices
- Summarize post-marketing surveillance and risk management data for the target device
- Work in cross-functional teams with strong communication, presentation, and interpersonal skills
- Demonstrate analytical thinking skills with strong scientific writing and verbal communication
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