Prin Regulatory Affairs Spec - Global Harmonization
Medtronic
- Location
- Bogotá, Bogota, Colombia
- Work model
- On-Site
- Level
- Senior
- H-1B history
- 106 approvals (FY2023)
- Posted
- 17h ago
About this role
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 This role serves as a key driver of Medtronic’s global regulatory advocacy and policy strategy, with a primary focus on advancing global harmonization of medical device regulations. The individual partners closely with regional and cross functional experts to monitor, interpret, and influence evolving regulatory policies, develop enterprise advocacy positions and high quality materials, and lead coordinated engagement with regulators and industry groups worldwide. Operating in a fast paced, highly matrixed, and global environment, the role translates complex regulatory issues into clear guidance and targeted actions that support timely patient access to safe, effective, and innovative medical technologies. Responsibilities may include the following and other duties may be assigned: Define, align, and execute global regulatory advocacy strategies in partnership with regional and functional SMEs, with emphasis on global harmonization Develop and lead high-quality advocacy materials (white papers, talking points, presentations) and coordinate enterprise-wide input and alignment Lead external commenting on regulations and guidances; participate in industry working groups and engage with regulators and associations as directed Establish and manage internal working groups, tools, playbooks, and training to enable coordinated, globally harmonized advocacy Monitor global regulatory trends and emerging issues, translate enterprise strategy into targeted regional actions, and maintain advocacy trackers and SharePoint resources Required Knowledge and Experience: Bachelor's Degree Five to seven years of experience in regulatory advocacy and influencing healthcare policy in a global, matrixed environment. Strong understanding of international medical device regulations, guidelines, and regulatory policy frameworks. Technical regulatory knowledge across key areas such as postmarket surveillance, MDSAP, clinical evidence, and/or human factors. Excellent written, verbal, and visual communication skills to synthesize complex regulatory concepts into clear, persuasive materials 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 benefits, resources, and