About the position
A career at Medtronic is like no other. We're purposeful. We're committed. We're driven by our Mission to alleviate pain, restore health, and extend life for millions of people worldwide. We believe career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. We offer award-winning programs to accelerate your development and growth, and our size, scope, and market leadership help you explore career opportunities and grow as we grow. Medtronic walks the walk, creating an inclusive culture where you can thrive. We believe that when people from different cultures, genders, and points of view come together—everyone wins. We are seeking a Senior Medical Safety Specialist (Diabetes) for a fully remote opportunity providing medical expertise and assessment to support patient safety throughout the product lifecycle as both an advocate for patient safety and in support of safe and effective use of Diabetes products and therapies. The Diabetes product portfolio includes insulin pumps, continuous glucose monitors, insulin pens, consumables, and multiple applications. The Senior Medical Safety Specialist provides technical and clinical information regarding product usage and performance -- specifically as it relates to patient safety -- on a range of medical safety activities of varying complexity in collaboration with Medical Safety team members and other functions, including Regulatory, Quality Post-Market vigilance, Risk Management, Complaint Handling, Product Development, and Medical Affairs. They primarily interact with medical safety team members (and other functions as needed) to gather information or gain input to support decision-making. They may occasionally interact in a supportive role with external physicians. In this role, you will leverage your medical knowledge, clinical expertise, and product knowledge to support patient safety. You will evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes. You will author high-quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate. You will critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new events with a causal relationship to the device) per business unit processes for investigation assessment and action. Additionally, you will assist with obtaining input from external medical and subject matter experts on safety matters and complete qualitative and quantitative assessments of post-market adverse events, medical significance, and recommendations for inclusion in regulatory annual reports. You will provide evidence-based medical safety input, education, and/or response to safety inquiries from internal or external stakeholders (e.g., external medical personnel or other third parties, including regulatory agencies or health care organizations).
Responsibilities
- Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle.
- Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes.
- Author high-quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate.
- Critically assess and escalate newly identified safety issues per business unit processes for investigation assessment and action.
- Assist with obtaining input from external medical and subject matter experts on safety matters.
- Complete qualitative and quantitative assessments of post-market adverse events, medical significance, and recommendations for inclusion in regulatory annual reports.
- Provide evidence-based medical safety input, education, and/or response to safety inquiries from internal or external stakeholders.
- Acquire and maintain proficient knowledge of assigned products and therapies, including device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile.
- Actively acquire and maintain knowledge of relevant scientific literature associated with assigned devices/therapies.
- Acquire and maintain advanced knowledge of applicable business unit policies/procedures, and relevant regulatory requirements and guidelines.
- Maintain an advanced understanding of key business processes involving Medical Safety.
- Work effectively across the matrix.
- Develop solutions and lead opportunities to advance and improve safety practices.
- May lead other projects that span outside of Medical Safety, as assigned in part or in entirety.
- Lead and influence evidence-based medical decision-making across the matrix organization.
- Provide strategic input and influence business strategies to optimize Medical Safety value.
- Interpret, analyze, and effectively communicate medical assessment across a variety of levels and audiences.
- Adapt verbal and written communication style to situational context.
- Adapt to changing priorities and work demands.
Requirements
- Bachelor's degree in Nursing required.
- Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience (e.g., RN, MD, PA, NP) including a minimum of four years of clinical experience in Diabetes care, or if an advanced degree (Master's or above), a minimum of two years of clinical experience in Diabetes.
- At least four years of experience with insulin pump therapy and continuous glucose monitoring.
Nice-to-haves
- Ability to perform patient assessments.
- 3+ years experience in the medical device industry preferred.
- Basic ability to understand and apply medical and product knowledge in a competent manner for Medical Safety activities.
- Able to make competent, risk-based, and timely medical safety decisions based on insightful analysis of critical information; able to balance analysis with decisiveness.
- Able to understand scientific/technical concepts and function of medical devices.
- Excellent verbal and written communication skills to effectively convey messages and influence diverse stakeholders.
- Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications specific to the cardiac dysrhythmia population.
- Versatile learner, able to quickly and effectively integrate new information and skills.
- Divergent thinker with solid critical thinking and problem-solving skills. Must be able to reach determined goals by prioritizing workload effectively and independently.
- High attention to detail and accuracy; able to work independently with minimal supervision; accountable for outcomes.
- Able to develop trusted relationships and collaborate with peers, co-workers, and key functional partners.
- Good understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), Food and Drug Administration (FDA).
- Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions.
Benefits
- Short-term incentive plan eligibility
- Wide range of benefits, resources, and competitive compensation plans designed to support employees at every career and life stage.
