Senior Clinical Evaluation Report(clinical writer)

📌 Core Information

🔹 Job Title: Senior Clinical Evaluation Report (Clinical Writer)

🔹 Company: Siemens

🔹 Location: Bangalore, Karnataka, India

🔹 Job Type: Full-Time

🔹 Category: Medical Device Industry

🔹 Date Posted: June 9, 2025

🔹 Experience Level: 7-10 years

🔹 Remote Status: On-site

🚀 Job Overview

Key aspects of this role include:

• Independently developing and updating Clinical Evaluation Reports (CERs) for medical device products
• Compliance with regulatory submission requirements, particularly EU MDR and MEDDEV guidelines
• Significant experience in clinical writing, medical writing, and technical writing
• Thorough knowledge of diagnostic radiology, interventional radiology, and radiation oncology

ASSUMPTION: This role requires a high level of autonomy and expertise in clinical evaluation report writing, with a focus on medical device regulations and therapeutic area knowledge.

📋 Key Responsibilities

✅ Develop and update Clinical Evaluation Reports (CERs) that support regulatory submission requirements for medical device products

✅ Ensure CERs comply with EU MDR and MEDDEV guidelines

✅ Collaborate with cross-functional teams to gather and integrate clinical evaluation data

✅ Stay updated with changes in regulatory landscape, device functionalities, and therapy areas

✅ Review and provide feedback on CERs written by others

ASSUMPTION: This role involves a significant amount of independent work, requiring strong self-motivation and attention to detail.

🎯 Required Qualifications

Education: Master's degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience

Experience: 7-8 years of experience, including 4-5 years specifically in CER writing and reviewing, with a focus on EU MDR and MEDDEV 2.7/1

Required Skills:

• Proven experience in clinical writing, medical writing, and technical writing
• In-depth knowledge of diagnostic radiology, interventional radiology, and radiation oncology
• Familiarity with various country-specific standards and regulations for medical devices
• Excellent written and verbal communication skills in English

Preferred Skills:

• Experience with writing CERs that conform to MEDDEV 2.7/1
• Knowledge of other relevant therapeutic areas

ASSUMPTION: Candidates with recent and relevant experience in CER writing and reviewing, along with a strong background in medical/life sciences, will be most competitive for this role.

💰 Compensation & Benefits

Salary Range: INR 15,00,000 - 20,00,000 per annum (Estimated based on industry standards for the role and experience level)

Benefits:

• Competitive health insurance and retirement plans
• Employee stock purchase plan
• Tuition assistance and professional development opportunities
• Flexible work arrangements and paid time off

Working Hours: Full-time (40 hours/week), with flexibility for project demands

ASSUMPTION: The provided salary range is an estimate based on industry standards for the role, experience level, and location. Actual compensation may vary based on factors such as skills, experience, and internal equity.

📌 Applicant Insights

🔍 Company Context

Industry: Siemens operates in the medical device industry, focusing on precision diagnostic solutions for positron emission tomography (PET) imaging

Company Size: Siemens has 201-500 employees in this specific division, offering a mid-sized company environment

Founded: The Advanced Accelerator Applications division of Siemens was founded in 2002, focusing on molecular imaging and radiopharmaceutical products

Company Description:

• Siemens is a global leader in medical technology, providing innovative solutions for healthcare providers and patients worldwide
• The Advanced Accelerator Applications division specializes in precision diagnostic solutions for PET imaging, with a focus on oncology and expanding into neurology
• The company's core mission is to develop, manufacture, test, and timely supply radiopharmaceutical products for patients in need

Company Specialties:

• Molecular imaging
• Radiopharmaceutical products
• Positron emission tomography (PET) imaging
• Oncology and neurology

Company Website: Siemens Healthineers

ASSUMPTION: Siemens offers a dynamic work environment with a strong focus on innovation and patient care, providing opportunities for professional growth and development.

📊 Role Analysis

Career Level: This role is at the senior level, requiring extensive experience and expertise in clinical evaluation report writing

Reporting Structure: The Senior Clinical Evaluation Report Writer will report directly to the Clinical Evaluation Manager

Work Arrangement: This role is on-site, with flexibility for remote work based on project demands and team needs

Growth Opportunities:

• Expanding knowledge and experience in other therapeutic areas
• Developing leadership skills through mentoring and knowledge sharing
• Potential career progression into management or specialized clinical roles

ASSUMPTION: This role offers opportunities for professional growth and development, particularly in expanding therapeutic area knowledge and honing leadership skills.

🌍 Location & Work Environment

Office Type: Siemens operates a modern and collaborative office environment, with state-of-the-art facilities for medical device development and manufacturing

Office Location(s): Bangalore, Karnataka, India

Geographic Context:

• Bangalore is a major tech hub and the capital of Karnataka, offering a vibrant and multicultural work environment
• The city is known for its pleasant climate, with moderate temperatures throughout the year
• Bangalore offers a mix of traditional and modern amenities, with a wide range of housing, dining, and entertainment options

Work Schedule: Full-time (40 hours/week), with flexibility for project demands and team needs

ASSUMPTION: Bangalore offers a dynamic and multicultural work environment, with a strong focus on technology and innovation, providing ample opportunities for professional growth and development.

💼 Interview & Application Insights

Typical Process:

• Online application submission
• Phone or video screening
• On-site or virtual interviews with hiring managers and team members
• Background check and offer extension

Key Assessment Areas:

• Clinical evaluation report writing skills and experience
• Knowledge of medical device regulations and therapeutic areas
• Communication and interpersonal skills
• Problem-solving and analytical skills

Application Tips:

• Highlight relevant experience in CER writing and reviewing, with a focus on EU MDR and MEDDEV guidelines
• Tailor your resume and cover letter to emphasize your clinical evaluation report writing skills and experience
• Prepare examples of CERs you've written or reviewed, demonstrating your ability to meet regulatory submission requirements

ATS Keywords: Clinical Evaluation Report, CER, Medical Device Regulations, EU MDR, MEDDEV, Diagnostic Radiology, Interventional Radiology, Radiation Oncology, Clinical Writing, Medical Writing, Technical Writing

ASSUMPTION: The application process for this role is likely to be competitive, with a strong focus on assessing candidates' clinical evaluation report writing skills and experience.

🛠️ Tools & Technologies

• Microsoft Office Suite (Word, Excel, PowerPoint)
• Adobe Acrobat DC
• Regulatory submission software (e.g., RABS, Veeva Vault)
• Project management tools (e.g., Microsoft Project, Asana)

ASSUMPTION: The tools and technologies required for this role are standard in the medical device industry, with a focus on regulatory submission software and project management tools.

👔 Cultural Fit Considerations

Company Values:

• Innovation
• Quality
• Customer focus
• Responsibility
• Openness and respect

Work Style:

• Collaborative and team-oriented
• Results-driven and focused on delivering high-quality work
• Adaptable and responsive to changing project demands and priorities

Self-Assessment Questions:

• Do you have a strong passion for innovation and improving patient care through medical technology?
• Are you comfortable working in a dynamic and collaborative team environment, with a focus on delivering high-quality results?
• Do you thrive in a fast-paced and adaptable work environment, with a strong focus on meeting regulatory submission requirements?

ASSUMPTION: Siemens values a strong work ethic, collaboration, and a focus on delivering high-quality results, with a particular emphasis on innovation and customer focus.

⚠️ Potential Challenges

• Keeping up with rapid changes in regulatory landscape, device functionalities, and therapy areas
• Managing multiple projects and deadlines simultaneously
• Working independently and taking ownership of CER development and review processes
• Adapting to a dynamic and fast-paced work environment, with a strong focus on meeting regulatory submission requirements

ASSUMPTION: This role presents unique challenges related to the fast-paced nature of the medical device industry, requiring strong adaptability, attention to detail, and a commitment to meeting regulatory submission requirements.

📈 Similar Roles Comparison

• This role is similar to other senior clinical evaluation report writer positions in the medical device industry, with a focus on regulatory submission requirements and therapeutic area knowledge
• However, this role may differ in terms of the specific therapeutic areas and regulatory environments, as well as the size and structure of the organization
• Career progression in this role may involve expanding therapeutic area knowledge, developing leadership skills, or specializing in specific clinical or regulatory areas

ASSUMPTION: While this role shares similarities with other senior clinical evaluation report writer positions, the specific therapeutic areas, regulatory environments, and organizational structures may vary, offering unique opportunities and challenges.

📝 Sample Projects

• Developing a Clinical Evaluation Report for a new medical device product, ensuring compliance with EU MDR and MEDDEV guidelines
• Reviewing and providing feedback on CERs written by other team members, ensuring consistency and adherence to regulatory submission requirements
• Collaborating with cross-functional teams to gather and integrate clinical evaluation data, ensuring a comprehensive and accurate CER

ASSUMPTION: These sample projects reflect the core responsibilities of the Senior Clinical Evaluation Report Writer role, with a focus on CER development, review, and collaboration with cross-functional teams.

❓ Key Questions to Ask During Interview

• Can you describe the typical timeline for developing and submitting a Clinical Evaluation Report for a medical device product?
• How does the team collaborate and integrate clinical evaluation data from various sources to ensure a comprehensive and accurate CER?
• What opportunities are there for professional growth and development in this role, particularly in expanding therapeutic area knowledge or honing leadership skills?
• How does the company support employees in keeping up with rapid changes in the regulatory landscape, device functionalities, and therapy areas?
• What is the company's approach to work-life balance, particularly in a role that may involve managing multiple projects and deadlines simultaneously?

ASSUMPTION: These key questions are designed to provide insight into the day-to-day responsibilities, team dynamics, and professional growth opportunities in this role, as well as the company's approach to supporting employees in meeting the unique challenges of the medical device industry.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through the Siemens careers portal
• Tailor your resume and cover letter to highlight your relevant experience in CER writing and reviewing, with a focus on EU MDR and MEDDEV guidelines
• Prepare examples of CERs you've written or reviewed, demonstrating your ability to meet regulatory submission requirements
• Follow up with the hiring manager within one week of submitting your application to express your interest in the role

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.