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Senior Medical Safety Specialist

Medical Affairs
19000HWV Requisition #

The Brain Therapies division of the Restorative Therapies Group offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neurosurgical procedures. Key areas of focus for the Brain Therapies division include: Parkinson’s disease, Brain tumors, Hydrocephalus, Acute ischemic stroke, Hemorrhagic stroke, Arteriovenous malformation. The Brain Therapies division consists of five businesses, including the Neurovascular group based in Irvine,CA. Key therapies addressed by the Neurovascular group include; Acute ischemic stroke
and Hemorrhagic stroke.

Careers That Change Lives

The Senior Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the lifecycle.  A primary responsibility will be to provide 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 Affairs.   

A Day in the Life
You will apply your medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of Medical Knowledge and Experience:
  • Medical Input:  
Maintain medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas.
Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle where the Medical Safety role is defined.
  • Medical Safety Assessments:  
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 event with 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.   
  • Safety Inquiries: 
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).
  • Product and Therapy Knowledge:
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.

  • Business Acumen:
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 as assigned in part or in entirety that span outside of medical safety.
  • Medical Communication and Influence:
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.  
Must Have, Minimum Requirements  
  • Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience.
  • Bachelor’s degree or higher in a biologic science  
  • Minimum 4 years of clinical experience Or advanced degree and  a minimum 2 years of clinical experience.
Nice To Have  
  • Degree towards healthcare or medical profession (e.g., nurse, nurse practitioner, physician assistant, or other related medical/scientific field).  
  • Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications with a preference towards neurovascular experience. 
  • Excellent verbal and written English communication skills
  • 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.
About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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 the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


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