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Medical Affairs
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19000J0F Requisition #
SENIOR MEDICAL SAFETY MANAGER

Careers that Change Lives

Safety and Product Platform serve as an integral role within the Global Medical Affairs organization of the Surgical Innovations (SI) Business, which is part of the Minimally Invasive Therapies Group (MITG). SI is the largest business division focused on a wide range of surgical medical devices and technologies used in many different surgical procedures in Obesity and Metabolic Health, Colorectal, Thoracic, Hernia and General Surgery. 

The Senior Medical Safety Manager, as part of the Product Platform & Safety Function, will provide clinical insights to both product development (pre-market) and maintenance of legacy devices (post-market).  He/She will support the functional leader in assessment and mitigation of device-related harms by using the perspective of the surgeon and the patient to drive appropriate actions meant to ensure surgically relevant, safe products and to protect patient safety when devices are used operatively. 

A Day in the Life

  • Provides medical expertise and assessment to support patient safety throughout the lifecycle. Review, and serve as escalation point for medically-associated deliverables to NPD, legacy, and compliance processes, including Issue Impact Assessments (IIA), and Preliminary Harms Analysis (PHA)
  • 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: Licensed 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.

Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum of 7 years of medical assessment experience supporting patient safety with 5+ years of managerial experience, 
  • Or advanced degree with a minimum of 5 years of medical assessment experience supporting patient safety with 5+ years of managerial experience

Nice to Have
  • Clinical background with direct product use experience
  • MD would be considered a differentiation

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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