Terumo Aortic is a leading global medical device company dedicated to advancing medical technology and ensuring regulatory compliance. We are experiencing a time of unprecedented growth and investment, and we invite you to join our dynamic team. We are currently looking for a Medical and Scientific Writer (I) in our Clinical Affairs department, you will play a pivotal role in creating and updating essential clinical documents. You will work within a collaborative environment to ensure the highest standards of quality and compliance with relevant medical device regulations.

The Key Responsibilities of the role are;

Document Creation and Updates:

• Write and maintain Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Follow-up Evaluation Reports (PMCFRs), and Summaries of Safety & Clinical Performance (SSCPs) for Class III cardiovascular medical devices.
• Conduct scientific literature reviews, including the preparation of literature search reports.
• Analyse clinical and post-market surveillance data to evaluate the safety and performance and benefit-risk ratio of the device under evaluation.

Collaboration and Liaison:

• Work with departments such as Clinical Affairs, R&D, QA, Risk Management, Sales & Marketing, and Regulatory Affairs to gather necessary information for CERs.
• Assist the team in responding to Notified Body/Regulatory Authority queries related to clinical data or the clinical evaluation process.

Regulatory and Quality Compliance:

• Stay updated with regulations and guidance documents related to clinical evaluation, PMCF, and SSCPs, and relevant clinical practice guidelines.
• Ensure compliance with internal procedures and Medical Device Regulations (MDR) 2017/745, Medical Device Directive (MDD) 93/42/EEC, relevant MDCG guidance, and MEDDEV 2.7/1 revision 4.

Additional Responsibilities:

• Provide clinical data for regulatory submissions and other departmental needs.
• Conduct ad-hoc literature reviews as required.
• Contribute to the review and update of Instructions for Use and Marketing Collateral.
• Assist in maintaining team SOPs and participate in project teams as the Medical & Scientific Writing Team representative.

The successful candidate will possess;

Essential:

• Degree in a relevant discipline (e.g., Life Sciences, Biomedical Engineering).
• Experience in conducting scientific literature reviews.
• Strong analytical and data interpretation skills.
• High attention to detail and accuracy in documentation.
• Excellent communication and time management skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Desirable:

• Experience in technical, scientific, or regulatory writing.
• Familiarity with the cardiovascular system and/or the medical device industry.
• Experience analysing clinical data.
• Experience authoring CEPs, CERs, PMCFRs, and SSCPs.
• Familiarity with the MDR and associated MDCG guidance documents.