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A Day in the Life

Careers That Change Lives

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 give you a chance to 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.

The Senior Medical Safety Specialist (SMSS) is responsible for providing medical expertise and assessment to support patient safety throughout the lifecycle as both an advocate for patient safety and in support of the safe and effective use of surgical robotics products and therapies.

With limited oversight, the SMSS works on a range of medical safety activities of varying complexity, in collaboration with MS team members and other functions, including Regulatory, Quality, Risk Management, Complaint Handling, Product Development, and Medical Affairs. The Sr MS Specialist represents the MS function on Medtronic cross-functional teams, and interacts with senior internal and external customers, including expert physicians.  

A strong clinical background in surgery/operating room is needed for this role. Additional experience with robotics is beneficial. Responsibilities may include the following and other duties may be assigned.

• Provides medical expertise and assessment to support patient safety throughout the lifecycle.
• Provides technical and clinical information regarding product usage and performance, specifically regarding patient safety.
• Collaborates with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical Affairs.
• Maintains medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas.
• Leverages medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle.
• Acquires and maintains 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 acquires and maintains knowledge of relevant scientific literature associated with assigned devices/therapies.
• Evaluates events and potential safety signals identified through Quality, Clinical, and Regulatory-related business unit processes.
• Authors high-quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate.
• Critically assesses and escalates newly identified safety issues per business unit processes for investigation assessment and action.
• MD Designation only: MD may also need create and provide clinical information and safety reports as required by regulatory agencies including adverse events data from clinical trials and/or consumer usage, spontaneous or solicited sources, periodic and experience reports.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• A clinical background in surgery/operating room is required for this role.
• Additional experience with surgical robotics is highly beneficial, but not required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform