Sr Medical Safety Specialist - Endoscopy

Sr Medical Safety Specialist - Endoscopy

Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. About the role: Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. At Boston Scientific, our products and technologies are used to diagnose and treat a wide range of medical conditions. We continue to innovate in key areas while expanding our technologies into new geographies and high-growth adjacent markets. Within the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the gastrointestinal and pulmonary systems. Our comprehensive portfolio includes diagnostic and therapeutic solutions such as balloon dilation, stent placement, ERCP with cholangioscopy, tissue biopsy and polypectomy, hemostatic techniques, radiofrequency ablation, infection control solutions, endobariatrics and enteral nutrition support. Backed by a strong product portfolio and pipeline, we remain committed to advancing patient care through continued innovation. The Senior Medical Safety Specialist Endoscopy manages surveillance processes across a broad range of gastrointestinal, endobariatric and pulmonary products and disease states. This role performs accurate, timely and consistent medical assessments of adverse events and potential adverse events to provide medical expertise, objective oversight and safety vigilance throughout the total product life cycle. The position partners closely with Clinical, Regulatory, Quality, Post Market Surveillance, the Complaint Management Center and cross-functional leadership while operating with limited oversight from the Medical Safety Manager and/or Medical Director. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time. Your responsibilities will include: Apply clinical knowledge and experience to support a broad portfolio of medical devices across one or more therapeutic areas. Receive and analyze data from multiple sources, including clinical trials, complaints and Medical Device Reports, to identify potential safety issues and contribute to internal and external medical safety reporting. Escalate potential patient safety concerns to senior leadership for review, decision-making and appropriate action. Review and approve promotional and sales training materials for medical accuracy. Represent Medical Safety on cross-functional team meetings. Partner with the Medical Director and Medical Safety Manager to communicate complex medical and scientific information clearly and effectively. Identify and implement opportunities for continuous quality improvement. Apply working knowledge of global medical device regulations and standards, including EU MDR and EUDAMED requirements. Qualifications: Required qualifications: Bachelor's degree in a health care, life sciences or related field, or an equivalent combination of education and experience. Minimum of 5 years' experience providing direct patient care. Qualified backgrounds include, but are not limited to, registered nurses, physician assistants and nurse practitioners. Minimum of 5 years' experience in clinical or scientific research, preferably supporting medical device clinical trials. Understanding of applicable medical device safety regulations and guidelines, including those issued by the U.S. Food and Drug Administration, the European Union and other global regulatory agencies. Strong analytical skills with the ability to interpret scientific and medical data, manage multiple priorities and solve complex problems. Ability to make sound independent decisions, evaluate complex medical information and lead projects with minimal supervision. Excellent organizational, project management and time management skills. Strong knowledge of regulatory requirements and medical terminology. Excellent technical writing, editing and proofreading skills. Strong verbal, written and computer skills. Demonstrated ability to build effective cross-functional relationships and collaborate across teams. Ability to coordinate multiple priorities and manage complex projects independently. Preferred qualifications: Direct patient care experience in interventional endoscopy and/or interventional pulmonology. Post Market Surveillance experience within the medical device industry.