SENIOR REGULATORY AFFAIRS SPECIALIST. (E-158)

Medtronic


At Medtronic, you can start a lifelong career ofexploration and innovation while helping champion healthcare accessand equity for all. You’ll lead with purpose, breaking downbarriers to innovation in a more connected, compassionate world. ADay in the Life Medtronic is one of the largest medical technologycompanies globally. Through innovation and collaboration, Medtronichelps alleviate pain, restore health, and extend life. Last year,our medical therapies for over 40 major conditions improved thelives of more than 75 million people worldwide. Role Overview: TheSenior Regulatory Affairs Specialist coordinates and preparesdocument packages for regulatory submissions. This role is hybridbased in Bogotá, Colombia. Responsibilities may include: 1.Coordination and preparation of document packages for regulatorysubmissions across all company areas, including internal audits andinspections. 2. Leading or compiling materials required forsubmissions, license renewals, and annual registrations. 3.Recommending changes to labeling, manufacturing, marketing, andclinical protocols for regulatory compliance. 4. Monitoring andimproving tracking/control systems. 5. Staying updated onregulatory procedures and changes. 6. Interacting directly withregulatory agencies on defined matters. 7. Recommending strategiesfor the earliest possible approvals of clinical trial applications.Required Knowledge and Experience: 1. Bachelor’s degree. 2. Atleast four years of experience in regulatory affairs or operations.3. Fluent in English. 4. Proficient in Microsoft Office (Outlook,Excel, Word, PowerPoint). 5. Growth and global mindset. 6. Abilityto work in a matrix-structured organization. 7. Experience with SAPand GTS is advantageous. Physical Job Requirements: The statementsare intended to describe the general nature and level of work butare not exhaustive of all responsibilities and skills required.Benefits & Compensation Medtronic offers a competitive salaryand flexible benefits package. We value our employees and recognizetheir contributions, offering a wide range of benefits andresources to support every career and life stage. This position iseligible for a short-term incentive called the Medtronic IncentivePlan (MIP). About Medtronic We lead global healthcare technologyand boldly address the most challenging health problems facinghumanity by seeking innovative solutions. Our mission — toalleviate pain, restore health, and extend life — unites a globalteam of over 95,000 passionate people. We are engineers atheart—transforming ambitious ideas into real solutions for realpeople. From R&D; to manufacturing to the conference room, weexperiment, create, build, improve, and solve. We have the talent,diverse perspectives, and courage to engineer the extraordinary.Learn more about our business, mission, and commitment to diversityhere. #J-18808-Ljbffr

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