Product Risk Specialist II

Skip to main contentDashboardProfileJoin Talent NetworkSign InEnglishSingle PositionView All JobsProduct Risk Specialist IIGlobal Park, La Aurora de Heredia, Costa Rica | Costa Rica-Heredia No longer accepting applications.Work ModeHybridRequisition ID630953Additional Locations: Costa Rica-HerediaDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.Hybrid Roles:Boston Scientific's hybrid workplace includes Working From Home and onsite. You will have the opportunity to discuss details in the interview. About the role:The Scientific Communications Specialist II contributes to clinical evaluation and post-market clinical follow up reporting for the BSC Urology Division. Typical deliverables include literature reviews, clinical evaluation plans and reports (CEP/CER), post-market clinical follow-up plans and evaluation reports (PMCF-P/PMCF-ER). This role supports product approval, market expansion, and mandated post-market requirements and partners closely with more senior members of the Scientific Communications team as well as cross-functional partners in Regulatory Affairs, Research & Development, Design Quality Assurance, Clinical Strategy, Clinical Operations, and Medical Safety.Your responsibilities include:Update CERs and related documents (CEPs, PMCF Plans, PMCF Reports, SSCPs) by incorporating clinical investigation data, PMCF data, and scientific literature; reviewing hazard analyses and other risk documents, reviewing product complaint data, and analyzing scientific data.Conduct literature reviews, screening literature and extracting relevant data elements. Contribute to generating and updating state of the art reports characterizing disease states, clinical outcomes, and therapeutic alternatives for assigned device portfolios. Contribute to medical writing of study reports for BSC-sponsored real-world evidence studies, PMCF activities, and systematic literature review and meta-analysis reports.Contribute to addressing clinical queries from regulatory bodies in support of product safety and performance.Coordinate cross-functional stakeholder teams for input, review, and approval of assigned deliverables and projects.Manage document timelines required by BSC procedures, product development teams, clinical teams, and global Regulatory Bodies.Develop understanding of assigned therapeutic areas, devices, and alternative therapies.Contribute as a participant in new product development and sustaining core teams, contributing to clinical evaluation and cross-functional deliverables.Contribute input into hazard analyses and instructions for use for assessment of potential harms and support of product safety and performance.Contribute to the review of cross-functional deliverables, including risk documentation and PSURs for assigned products. Develop knowledge in evolving requirements of international regulations, including requirements laid out in EU MDR.Contribute to CER process development and improvement activities.Contribute to team development activities (e.g. knowledge sharing, presenting in team meetings).What we’re looking for in you:Minimum QualificationsBachelor’s degree with 2+ years of related work experience (Clinical Evaluation / Medical Writing / Clinical Trials / Medical Affairs / Epidemiology)Knowledge of clinical research methodologies (clinical investigation design and biostatistics, systematic literature review)Ability to analyze, interpret, and...