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 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, Literature, MDR/Vigilance is primarily responsible for providing support of activities supporting compliance with the Medical Device Regulations.  The Medical Safety (MS) Specialist will support patient safety throughout the lifecycle as both an advocate for patient safety and in support of safe and effective use of assigned products and therapies.

With limited supervision, the Sr. Medical Safety Specialist, Literature, MDR/Vigilance provides a review of medical literature for Post-Market Product Surveillance. This position will continually monitor the safety and risk/benefit profile of products distributed, marketed, and sold by Medtronic’s Minimally Invasive Therapies Group (MITG). You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance (PMV), Regulatory, and Clinical Affairs. This role requires a skilled critical thinker who is self-motivated and able to work independently and collaboratively within a team.

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 as it relates to 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 to 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, and periodic and experience reports.

Required Knowledge and 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.

• RN and/or a a strong clinical background in the surgical/operating room and/or ICU environment is preferred.

• May have practical knowledge of project management.

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

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 exhaus