Clinical Affairs Professional

4 days ago

Bengaluru, India Siemens Healthineers Full time

Preferred Education: Masters degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience

Preferred Experience:

- 1. The expected experience is 4-6 years with minimum 1-2 years of PSUR writing and reviewing experience. Significant experience writing scientific, medical/clinical, and technical content.
- 2. Knowledge in the therapeutic area 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.

**Responsibilities**:
1. Collaborate with the project/program stakeholders for product knowledge and information to develop quality content for the PSURs and within the required timelines.
- 2. Study and report device characteristics and instructions for use
- 3. Evaluate data for similar competitor devices
- 4. Summarize post-marketing surveillance and risk management data for the target device
- 5. Able to work in cross functional teams with strong communication, presentation & interpersonal skills
- 6. Analytical thinking skills with strong demonstration of scientific writing and verbal communication.

**Organization**: Siemens Healthineers

**Company**: Siemens Healthcare Private Limited

**Experience Level**: Experienced Professional

**Full / Part time**: Full-time

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