Siemens Healthcare is Hiring Clinical Affairs Professionals – Apply Now!

Siemens Healthcare Hiring! Life Sciences Clinical Affairs Professional Recruitment

Position: Clinical Affairs Professional

Location: Bengaluru, Karnataka, India

Job ID: 393834

Company: Siemens Healthcare Private Limited

Organization: Siemens Healthineers

Job Family: Quality Management

Experience Level: Mid-level Professional

Employment Type: Full-time

Work Location: Office/Site Only

Contract Type: Permanent

Position Summary

We are seeking an experienced Clinical Writer to join our team. The successful candidate will be responsible for independently contributing to the development of initial and updated Clinical Evaluation Reports (CERs) that support the regulatory submission requirements for our medical device products.

An ideal candidate will have a relevant medical/life-science qualification and direct clinical experience in using the device or device type in a clinical setting. The candidate should have 4-6 years of overall experience, with a minimum of 1-2 years of CER writing experience. Additionally, a minimum of 1-2 years of medical writing/reviewing experience is required. The candidate’s experience should be current or recent (preferably within the past two years) to ensure familiarity with the regulatory landscape, device functionalities, and the respective therapy area.

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

Preferred Experience

1. Expected experience of 4-6 years with a minimum of 1-2 years of CER writing and reviewing experience. Significant experience writing scientific, medical/clinical, and technical content. Experience with writing CERs that conform to MEDDEV 2.7/1 is a plus.
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 assess and provide device-appropriate clinical evaluation data for registrations.

Duties and Responsibilities

1. Collaborate with project/program stakeholders to gather product knowledge and information and develop quality content for the CERs within required timelines.
2. Screen and summarize literature for relevant clinical data.
3. Review literature to understand the clinical problem and current treatment techniques.
4. Study and report device characteristics and instructions for use.
5. Evaluate data for similar competitor devices.
6. Summarize post-marketing surveillance and risk management data for the target device.
7. Collaborate effectively within cross-functional teams, demonstrating strong communication, presentation, and interpersonal skills.
8. Demonstrate analytical thinking skills with strong scientific writing and verbal communication abilities.

To apply for this position, please visit the following link: Apply Now

Keywords: Siemens Healthcare, Life Sciences, Clinical Affairs Professional, Recruitment, Bengaluru, Karnataka, India, Clinical Writer, CER, Medical Devices, Medical Writing, Diagnostic Radiology, Interventional Radiology, Radiation Oncology, Regulatory Compliance. Siemens Healthcare Hiring! Life Sciences Clinical Affairs Professional Recruitment. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.