Medical writer/Clinical evaluation specialist medical device

Primary responsibilities-

- Develop knowledge and analyse the requirements for medical writing projects.

To understand and make strategy for drafting the CER, SVR CPR for any project.

Responsible for drafting of Scientific validity reports, clinical performance reports and Performance evaluation reports.

To design key words and strings required for the state of the art and device literature.

To perform literature search and summarize the SOTA and device literature.

Responsible for identifying and summarizing equivalence device information.

Responsible for remediating documents according to new medical device regulations

Responsible for drafting and submission of Clinical Evaluation Reports (CERs) for medical devices in compliance with MEDDEV 2.7.1 Rev 4, EU MDR 2017/745 guidelines.

Expertise in collating and reviewing CAPA (Corrective Action Preventive Action) and MAUDE database events.

Constant communication with the manufacturer in case of any additional requirements.

Responsible for training the team/members based on requirements.

Responsible for Identification of hazards and estimation evaluation and control of risk

Maintain and use necessary templates, formats, and styles to ensure that documents generated to meet industry and regulatory requirement.

• Plan, organize and manage daily work to meet service level timelines and deliverables and coordinate with various technical professionals to gather, organize and compile information on new products or processes.

Secondary Responsibilities:

• -Participate in quality processes and process improvement initiatives.

• Provide suggestions on event categorization and mapping to risk documents.