Regulatory Affairs Specialist at Medtronic

Job Description (adsbygoogle = window.adsbygoogle || []).push({}); Medtronic ), is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic’s mission is: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life. To direct our growth in the areas of biomedical engineering where we display maximum strength and ability; to gather people and facilities that tend to augment these areas; to continuously build on these areas through education and knowledge assimilation; to avoid participation in areas where we cannot make unique and worthy contributions. To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service. To make a fair profit on current operations to meet our obligations, sustain our growth, and reach our goals. To recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company’s success. To maintain good citizenship as a company. 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.A Day in the Life Performs coordination and preparation of document packages for regulatory submissions from all Operating Units and departments for countries across the regionCompiles all materials required in submissions, license renewal and annual registrations.Networks across departments to ensure that products are approved for the marketMonitors and improves tracking / control systems.Keeps abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Performs post market requirements Must Haves Minimum 3 years experience in regulatory affairsAbility to communicate effectively to all levels of the organization and customers in English (strong written and verbal skills)Strong MS office skillsAbility to work co-operatively in a matrix environmentCapability to establish and use networks to acquire information Nice to Haves SAP, Insight experience We OfferWe offer a competitive salary and benefits package to all our employees: Flexible working environmentAnnual Incentive Plan % depending on company resultsPension scheme and group discount on healthcare insuranceTraining possibilities via Cornerstone/Harvard Manage Monitor/Skills LabEmployee Assistance Program and Recognize! (Our global recognition program)