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 LifeAt 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. You will be working in Medtronic Clinical & Regulatory Solutions (MCRS), Data & Safety Management team.
There is no travel expected in this role, it is a hybrid role and the reporting will be to a European Manager. Responsibilities may include the following and other duties may be assigned: Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies Review non-AE Case Report Forms to detect potential complaint and potential unreported AEs.
Ensure consistency in the assessment of clinical safety events Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP) Work with Regulatory Affairs and the Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs) and potential complaints Act as liaison for safety-related questions (e. g.
, to study team, field support, monitors, and study sites) Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, and other documents as required Collaborate with Data Management and other departments on the development of case report forms, study specific safety reports, and other study specific forms. Required Knowledge and Experience: Education background Graduate in Life scienceEnglish speaking is a requirement to be successful in this role2-5 Years of experience in Clinical Safety Orientation to detail and team player.
Medical Device related experience would be desirable. Physical Job RequirementsThe 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. Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people.
From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here
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