Siemens Careers

Scientific Writer

Bengaluru, India
Quality Management

English (UK)

Job Description

Designation: Scientific Writer

Job Profile: The function of this role is to combine the understanding of the product and the medical device regulations and guidelines to support the product registrations/approvals. Also, this role will involve timely development of clinical evaluation plans and reports.

Principle duties and responsibilities:

1.      Writing clinical evaluation plans and reports according to the guideline/regulations (MEDDEV 2.7.1, MDR, China)

2.      Reviewing and extracting the relevant content form the input documents for the Clinical evaluation plan/report (technical file documents, marketing claims, post market surveillance data)

3.      Identifying and screening business and product relevant scientific literature

4.      Analyzing and interpreting study results and compiling literature search reports

5.      Gathering. evaluating and organizing the regulatory submissions for the ongoing projects

6.      Maintaining familiarity with the various country regulations

7.      Liaising and negotiating with the country contact for clarification to the regulatory authorities.

8.      Work with internal delivery team and other functions in-order to meet the specified success criteria of project

9.      Ensuring compliance (of products) with legal and normative requirements through proactive risk management and mitigation strategies

10.  Collaborate with onsite teams to improve process efficiency

11.  Drive best practices within the organization

Desired Qualification and Experience:

1.      Diploma or master’s in science or technical profession

2.      Able to demonstrate experience in writing of Clinical Evaluation Reports/technical writing

for Medical Devices.

3.      Experience in Audits of medical devices. (in the role of an auditor and as auditee, e.g. in an

 FDA Inspection)

4.      Good knowledge of the relevant Standards/Regulations for medical device manufacturers

(ISO 13485, ISO14971, 21CFR820, MDR, MDD etc.)

5.      Knowledge in Software (e.g. IEC 62304, Agile SW Development)

6.      Experience in the cooperation with intercultural, worldwide distributed teams

7.      Experience in Process management

8.      Experience in Project Management desirable

  1. Excellent written and verbal communication skills in English
  2. Dynamic and agile team player as well as a structured and goal-oriented person

Job ID: 100103

Organisation: Siemens Healthineers

Experience Level: Mid-level Professional

Job Type: Full-time

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