Assoc Regulatory Affairs Spec

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

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, Bogota, 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.

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 95,000+ 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