At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

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.

Careers that Change Lives

We are seeking a Senior Medical Safety Specialist, a fully remote opportunity, who will be primarily responsible for providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety.  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 (Medical Safety Medical Directors and Specialists), and other functions as needed, to share information or gain input to support decision-making on various aspects of patient safety. They may occasionally interact in a supportive role with external physicians.

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

• Leverage medical knowledge and advocate for patient safety by providing input to internal functions and business processes across the product life cycle promoting product safety.

• Apply knowledge of Cardiac Implantable Device management along with use of Programmers and Remote Monitoring Capabilities.

• 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 (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, relevant regulatory requirements, and guidelines (e.g., ISO 14971, Application of Risk Management, ISO 13485, Quality Management Systems), and applicable therapy area societal guidelines (e.g., ACC/HRS/EHRA guidelines).

• Maintain an advanced understanding of key business processes involving Medical Safety (e.g., risk management, post-market vigilance). 

• Work effectively across a matrixed organization.

• 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 Safet