Associate Reg Ops Specialist

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**:This position is part of the Regulatory Affairs Data and Product Release Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes. Primary responsibilities include supporting our Unique Device Identification (UDI) process and system to ensure global regulatory compliance and data integrity. Duties may include participating in projects supporting our Regulatory Affairs teams within the Operating Units and Regulatory Operations. This role primarily interfaces with regulatory affairs teams, operating unit (OU) regulatory teams, regulatory operations teams, manager and director.

A role in MCRS offers unique experience opportunities, such as: being part of a global team, collaborating with business partners throughout the company, visibility to global structures and impacts, and insight to various processes and functions across Medtronic.

This role is a hybrid position based in Bogota.

**Responsibilities may include the following and other duties may be assigned**:

• Activities related to enterprise-wide regulatory management systems, including systems coordination, training, developing and implementing plans, and providing input to systems designs.
• Performs Regulatory Operations activities including data transformation to support global UDI submissions
• Collaborates with global regulatory affairs teams and operation units to gather and analyze required information
• Participates actively in cross-functional teams to meet timelines, resolve regulatory issues, and improve work processes.

**Required Knowledge and Experience**

• Bachelor’s degree required
• 0 years of experience required
• Advanced proficiency in English
• High learning agility
• Organizational skills and highly detail oriented
• Flexible with changing priorities, self-motivated, strong work ethic, works well under pressure in a dynamic environment
• Analytical and problem-solving skills
• Document interpretation, queries and workflow skills
• Excellent communication skills

**Nice to Have**

• Experience in medical device
• Experience with regulatory affairs or quality
• Experience with UDI
• Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)
• Advanced communications skills (written and oral)
• Effective project management skills

**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.