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Boston Scientific Principal Medical Safety Specialist Job in Arden Hills, Minnesota

Additional Locations: Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work. About this role: The Principal Medical Safety Specialist is responsible for providing medical oversight across a range of products and disease states in electrophysiology and rhythm management, including diagnostic and therapeutic cardiac electrophysiology and cardiac implantable electronic devices. This health care professional collaborates directly with the Medical Director(s) and other team members cross-functionally to provide medical input and oversight throughout the product lifecycle as an advocate for patient safety. Uses subject matter expertise (practical medical and device knowledge) and clinical evidence to support Medical Director(s) and Vice President of Medical Safety in delivery of timely, accurate, and well-grounded medical safety perspective. On-site preferred, but remote option would be considered Your responsibilities include: Makes thoughtful, risk-based and timely medical safety decisions. Applies medical experience/product knowledge and critical thinking to support daily medical safety responsibilities. Performs medical review and assessment of adverse events, sources of which include but are not limited to clinical trials, complaints and Medical Device Reports (MDRs). Identifies potential safety signals for monitoring and trend analysis. Represents Medical Safety in associated cross-functional and cross-divisional meetings. Maintains deep understanding and ongoing proficiency of applicable products/therapies in order to assess potential risks and provide timely medical input to cross-functional teams. Note: support of specific product families may require enhanced technical expertise of both product and supporting systems. Performs pre-scheduled and ad hoc analyses of data from multiple sources and presents data by communicating accurate, succinct summaries at team and cross-functional meetings. Based on solid understanding of product design and use, provides input to product labeling in collaboration with cross-functional teams. Applies working knowledge of medical device regulations and standards (globally). Develops a solid network across the functions and divisions to support Medical Safety s collaboration with key functional stakeholders. Effectively escalates potential patient safety issues for decision-making and/or potential action by senior leadership. What we re looking for in you: Minimum Qualifications: Bachelor s degree in healthcare/life science related field 8 years of clinical or related experience Minimum of 2+ years of direct patient care experience, cardiac specific (ie: CCU, Cath Lab, EP Lab) Healthcare Licensure/Certification Preferred Qualifications: Recent clinical experience in the EP Lab: arrhythmia mapping and ablation procedures, pacemaker implants, ICD implants. Advanced knowledge of cardiac implantable device management and programming IBHRE Certification: CCDS and/or CEPS Related work experience in Medical Safety, Clinical Research, and/or Clinical Quality Knowledge/Experience with Clinical Trials (ie: research coordinator, research participation in practice) Experience with safety monitoring in medical device industry Demonstrated success in collaborating with and communicating effectively across different functions Master s in healthcare/clinical research related field About us As a global medical technology leader

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