Sr Medical Safety Specialist - Endoscopy

Boston Scientific • Maple Grove, MN

30d • $85,000 - $161,500 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• Direct patient care experience in interventional endoscopy and/or interventional pulmonology.
• Post Market Surveillance experience within the medical device industry.

Responsibilities

• 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.

Benefits

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
• Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior