Senior Medical Safety Specialist, Cardiac Ablation Solutions - Remote.

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We are seeking a Senior Medical Safety Specialist for a fully remote opportunity within our Enterprise team, who will be primarily responsible for providing technical and clinical information regarding product usage and performance, specifically related to patient safety for the Cardiac Ablation Solutions operating unit.

You will collaborate with multiple functions including Research and Development, Risk Management, Quality / Post-Market Vigilance, Regulatory, and Clinical to help deliver against our highest quality standards

The Senior Medical Safety Specialist works with minimal supervision 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 MS team members, and other functions as needed, to share information or gain input to support decision-making.

They may occasionally interact in a supportive role with external physicians.

A Day in the Life

You will apply your medical knowledge, clinical expertise, and product knowledge to support patient safety to support the following :

• Apply knowledge of diagnosis and treatment of cardiac rhythm disturbances and experience with a range of electrophysiology procedures (including EP studies, cryoablation, pulse field ablation (PFA), and radiofrequency ablation of arrhythmias including AF and VT, with Medtronic and / or other manufacturers’ systems and devices).
• 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 (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.
• 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 (e.

g., external medical personnel or other third parties, including regulatory agencies or health care organizations).

Acquire and maintain proficient knowledge of assigned products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.

e., hazards and harms).

• 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 (e.

g., ISO 14971, Application of Risk Management, ISO 13485, Quality Management Systems).

• Maintain an advanced understanding of key business processes involving Medical Safety (e.g., risk management, post-market vigilance).
• 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.
• Travel is required. Less than 10%.

Must Have : Minimum Requirements

• Bachelors degree required in Nursing or related healthcare field
• Licensed healthcare professional in related healthcare field
• Combination of Licensure and Medical Affairs / Safety or Clinical Management experience
• Minimum of 4 years of relevant experience conducting a range of electrophysiology procedures including cryoablation, pulse field ablation (PFA), radio frequency RF, AF and VT with Medtronic or comparable market devices, or advanced degree with a minimum of 2 years relevant experience.

Nice to Have

• Preferred lab experience using Medtronic ablation products.
• Preferred high-volume electrophysiology lab.
• Ability to perform patient assessments.
• 3+ years experience in the medical device industry preferred.
• Basic ability to understand and apply practical 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 message and influence diverse stakeholders.
• Solid medical background with the ability to apply 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.
30+ days ago