Clinical Safety Specialist

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Respicardia division of ZOLL Medical Corporation is focused on helping people with central sleep apnea get access to a therapy to restore a more normal breathing pattern during sleep and give them better quality of life. We develop breakthrough therapies for an impactful disease that is severely underdiagnosed and often untreated.

As we continue to grow, those who join our team will work alongside motivated people who care about others, put patients first and are dedicated to high-quality and innovative solutions.

Job Type / Schedule

Hybrid: Working from our Minnetonka Office location 3 days per week with the potential to work remotely 2 days per week.

Salary Details

Targeted Salary Range: $100,000-$110,000

Targeted 20% Annual Bonus

Job Summary

This position is responsible for leveraging patient-facing clinical experience to identify, evaluate, and manage safety signals for pre- and post-market medical devices. This role conducts safety data analysis, provides clinical insights for product development and trials, and collaborates with internal and external stakeholders to assess and communicate safety risks.

Essential Functions

• Perform professional clinical evaluations of medical device performance, clinical data from complaints, and impact on safety of products in development.
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal surveillance, detection, and processing.
• Support collection and documentation of all safety information for MDR certification (e.g., clinical evaluation report).
• Review, contribute, and approve risk and/or benefit-risk assessments (e.g., health hazard evaluations), including hazardous materials in support of materials compliance.
• Author safety assessments for multiple purposes and provide medical oversight/approval for any concern impacting potential safety of patients/donors.
• Review, contribute, and approve risk management plans and reports on behalf of medical safety.
• Contribute to relevant safety, risk management, and risk-benefit sections of clinical study documents (i.e., Clinical investigation plan, Investigator's brochure).
• Lead Clinical trial safety activities including coding and adjudication, if applicable.
• Manage Clinical Events Committee and Data Safety Monitoring Boards.
• Participate in clinical development plan for products to ensure clinical input and appropriate medical safety oversight.
• Review and contribute to the development of relevant clinical study documents (i.e., Informed consent form), clinical study reports, and manuscripts.
• Review and contribute to clinical risk documents.
• Collaborate with cross-functional product development teams on risk minimization activities and plans.
• Participate in and contribute to relevant field action/recall activities.
• Provide medical reviews of observations/complaints/AEs/SAEs to determine device and/or study relatedness and expectedness.

Required/Preferred Education and Experience

• Healthcare Clinical Background (MD, RN, CNS, NP, PA, or equivalent) required
• 3+ years of clinical/hospital experience following completion of postgraduate training required and
• 2+ years of clinical research/academic experience required and
• 2 years of pharma/biotech/medical device experience in a clinical or medical safety role preferred and
• Experience in sleep medicine or cardiology preferred

Knowledge, Skills and Abilities

• Knowledge and understanding of the global processes, regulations, and reporting requirements for medical device- and/or pharmaco-vigilance, including risk management and minimization activities
• Skilled in conducting literature searches, critically appraising research, and applying findings to safety evaluations, as needed
• Strong ability to apply medical concepts and terminology across clinical and non-clinical settings
• Proficient in analyzing various datasets, interpreting results, and conveying complex scientific data in a clear, concise, and understandable manner to both a scientific and non-scientific audience

Travel Requirements

• Ability to travel (including overnight stays) 10%

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.