Assoc Regulatory Affairs Spec

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life We are a mission-driven leader in medical technology and solutions, with a legacy of integrity and innovation. Work with us to advance better patient care and partner across the industry to make healthcare more affordable and accessible. Become part of a community of experts committed to ensuring high-quality, affordable healthcare worldwide. Come strengthen your specialized skills and grow your experience. We will support you with the training, mentorship, guidance, and networks you need to advance, empowering you to work in the way that suits you best. Together, we can take on challenges that will transform the future of healthcare. Join us to build a career that changes lives. This position will be based in Colombia, Bogotá, in a hybrid work model. Responsibilities may include the following and other duties may be assigned. Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections Lead or compile all materials required in submissions, license renewal and annual registrations Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance Monitor and improves tracking / control systems Keep abreast of regulatory procedures and changes May direct interaction with regulatory agencies on defined matters Recommend strategies for earliest possible approvals of clinical trials applications Required Knowledge and Experience: Bachelor’s degree in Pharmaceutical Chemistry, Biomedical Engineering, Medicine, Chemical Engineering, or related field, and/or practical experience in regulatory processes. 0-1 year of relevant experience in regulatory affairs within medical device companies Fluency in English (minimun B2 level required) Experience preparing/validating, renewing, and modifying health registrations. Experience working with regulatory agencies Nice to Have: Experience with medical device regulatory registrations Experience in internal and external audits and CAPA (Corrective and Preventive Actions) Certifications in Good Practices (GMP, GDP) and ISO 13485   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.  ‌ Recruitment Fraud Alert   We are aware of phishing scams targeting job seekers. Please keep the following in mind:  Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.  Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.  If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.  If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com .  ‌     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