Job Details

Medical Safety Manager

Company name
Medtronic, Inc.

Mansfield, MA

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Careers that Change Lives Medical Safety is primarily responsible for providing technical and clinical information regarding product usage and performance. This position will continually monitor the safety and efficacy of products marketed and sold by Medtronic MITG (Minimally Invasive Therapies Group) while serving internal and external customers. In addition, Medical Safety will establish and diligently maintain an open and educational relationship across multiple functional teams within Medtronic. Responsibilities include: managing safety investigations, executing and developing processes for safety assessments and surveillance, complaint analysis, interfacing with the Medical Affairs, Regulatory, Clinical Research, and Post-market Vigilance, and Risk Management departments. Risk Management activities will include assisting with assessment of harms to the patient, benefit-risks and communication of patient safety information. He/she will provide clinical and safety expertise to promote proactive safety surveillance for products across Medtronics Minimally Invasive Therapies Group. The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Impact patient outcomes. Come for a job, stay for a career. A Day in the Life Provides clinical and technical support of Medtronic MITG products. The support will include assisting Quality Assurance and Medical Affairs in addressing complex medical inquiries including assistance with the risk management documents, etc. Conduct medical evaluation of patient safety information from a variety of product data sources including clinical, post-market complaints, legal, and medical/scientific literature. Evaluate all MITG post-market surveillance Adverse Events, patient initiated files, legal, and medical/scientific literature Review competent authority requests and aide in timely response. Retrieve, disseminate, and archive pertinent data to appropriate parties. Participate on cross-functional teams concerned with development or support of products including research and development, quality engineering, medical affairs, clinical research, regulatory affairs and quality assurance. Provide professional consultation in matters related to safety, efficacy, and proper product usage as needed. Provide support for Product Monitoring with Post-Market Risk Analysis and/or Issue Impact Assessments Comply with all relevant related guidelines, standards and regulations pertaining to medical information provided to customers. Collaboratively and effectively communicate with various departments, including Legal Affairs, Regulatory Affairs, R & D, Engineering, Business Development Leadership, Marketing, Sales, and Customer Service, and potentially patients. Serve as the Safety representative providing medical safety input for the Minimally Invasive Therapies Group on new product development programs, clinical studies, and post-market surveillance. This individual will collaborate with the clinical affairs team on safety issues for the product development programs and clinical studies. Prepare safety response letters and medical to medical communications together with Medical Affairs clinicians and the Medical Safety Officer. Must Have: Minimum Requirements * Bachelors Degree in Nursing * Minimum of 5 years relevant experience Nice to Have: Ability to perform patient assessments Exceptional interpersonal skills and willingness to work in a team environment Well-developed written and communication skills Ability to work with a minimal amount of supervision. Strong organization skills with the ability to prioritize task and meet deadlines Effective analytical and problem solving Ability to coordinate and lead multiple projects simultaneously Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project) Quick to learn new computer systems with minimal assistance Effective at communicating via video conferencing when needed 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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future. 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 Day in the Life 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. EEO It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: ***************************************

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Company info

Medtronic, Inc.
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Company Profile
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Group’s products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.

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