Job Description
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 Peripheral Vascular Health (PVH) therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Artery Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease, caring for over 1 million patients globally with lifesaving and life-enhancing therapies. Regulatory Affairs is a key function within the business and this role is supporting the PVH business. Come for a job, stay for a career! The Associate Regulatory Affairs Specialist working under the guidance of more senior regulatory specialists/manager will provide support for PVH products. Emphasis is on the post market sustaining activities which includes maintaining regulatory approvals, assessment of device changes for registration implications and support in geo expansions registrations. A Day in The Life Contributes to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files and Global Submission Summary Document. Participates in preparation for and during internal and external regulatory audits Compiles materials required for new global product submissions, license renewals, change submissions and tenders. Monitors and improves global regulatory tracking/control systems Request, obtain and maintain FDA CFGs including notarization and legalization, EC/ISO certificates and various other regulatory documents. Participate in investigative activities such as CAPA's and non-conforming product Perform other regulatory affairs duties when requested Key Skills & Experience Bachelors Degree in health profession, science and/or engineering field Demonstrated technical writing skills. Strong computer skills, including word processing, spreadsheets and slide presentations Excellent organizational skills Strong written, verbal and interpersonal skills ? Medtronic offer a competitive salary and flexible Benefits Package #IJ 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. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A 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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We 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 90,000+ 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 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.