Sci Comm Specialist III at Boston Scientific Corporation Malaysia

La Asunción, Cantón de Belén, Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

31 Mar, 26

Salary

0.0

Posted On

31 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Evaluation, Medical Writing, Regulatory Affairs, EU MDR, Risk Management, Clinical Research, Analytical Skills, Communication Skills, Project Management, Attention to Detail, Organizational Skills, Literature Review, AI Technologies, Data Analysis, Cross-Functional Collaboration, Document Management

Industry

Medical Equipment Manufacturing

Description

Produce and maintain Clinical Evaluation Reports (CERs) and related documents (CEPs, PMCF Plans/Reports, SSCPs) for the global product portfolio by analyzing clinical data, risk documentation, complaints, and scientific literature, ensuring compliance with company SOPs and regional regulations (e.g., FDA 510(k)/PMA, EU MDR, Health Canada, PMDA) Contribute to literature reviews by screening and extracting relevant data using manual and AI-based methods, analyzing literature data, and developing state-of-the-art reports that summarize disease states, clinical outcomes, and therapeutic alternatives. Support AI transformation of literature reviews, including AI tool and workflow development, defining data elements, and maintaining data dictionaries. Contribute to clinical evaluation strategies, defining evidence requirements, safety/performance objectives, and PMCF plans. Contribute to addressing clinical queries from regulatory bodies regarding product safety and performance. Participate in new product development and sustaining projects, providing clinical evaluation input. Coordinate and collaborate with cross-functional teams to gather input, review, and approve deliverables. Manage document timelines to meet internal procedures and global regulatory requirements. Bachelor's degree and minimum of 3+ years of related work experience in Life Sciences, Biomedical Engineering, or related field (Clinical Evaluation / Medical Writing / Clinical Trials / Medical Affairs). Advanced Degree preferred (PhD, PharmD, MD). Experience in clinical evaluation, medical writing, or regulatory affairs within the medical device industry. Strong understanding of EU MDR and global regulatory requirements, along with knowledge of risk management principles and clinical research processes. Excellent analytical, writing, and communication skills. Ability to manage multiple projects and collaborate effectively in cross-functional teams. Experience writing CERs and related documents compliant with EU MDR Excellent attention to detail and strong organizational skills Solid understanding of business procedures, quality systems, and regulatory compliance Experience with systematic literature review methodologies and literature management software such as Distiller and EndNote Interest in or foundational training in AI technologies and their application in healthcare or scientific research and data analysis. A year in the current position, in the company. Performance Evaluation: Successful or above Don't have disciplinary actions in the last 6 months.

Responsibilities

The role involves producing and maintaining Clinical Evaluation Reports (CERs) and related documents while ensuring compliance with regulations. It also includes contributing to literature reviews and supporting AI transformation in clinical evaluation strategies.