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Medtronic
Medtronic

Medical device company.

Prin Regulatory Affairs Spec - Global Harmonization at Medtronic

RoleLegal
LevelPrincipal
LocationBogotá, Bogota, Colombia
WorkHybrid
TypeFull-time
Posted1 day ago
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About the role

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 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 Share Point 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.

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

Required skills

Regulatory affairs

Policy analysis

Advocacy strategy

Technical writing

Stakeholder alignment

Industry engagement

Training

Program coordination

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About Medtronic

Medtronic

Medtronic

Public

Medtronic plc is an American-Irish medical device company. The company's legal and executive headquarters are in Ireland, while its operational headquarters are in Minneapolis, Minnesota. Medtronic rebased to Ireland following its acquisition of Irish-based Covidien in 2015.

10,001+

Employees

Minneapolis

Headquarters

$100B

Valuation

Reviews

10 reviews

3.8

10 reviews

Work-life balance

3.2

Compensation

4.0

Culture

4.1

Career

3.5

Management

3.4

72%

Recommend to a friend

Pros

Supportive management and team culture

Excellent benefits and retirement plans

Cutting-edge technology and projects

Cons

Heavy workload and frequent overtime

Fast-paced and stressful environment

Limited growth opportunities

Salary Ranges

1,152 data points

Junior/L3

Junior/L3 · Advanced Analytics Analyst

3 reports

$95,911

total per year

Base

$73,778

Stock

-

Bonus

-

$66,383

$95,911

Interview experience

5 interviews

Difficulty

3.0

/ 5

Duration

14-28 weeks

Interview process

1

Application Review

2

Recruiter Screen

3

Technical Phone Screen

4

Onsite/Virtual Interviews

5

Offer

Common questions

Coding/Algorithm

Technical Knowledge

Behavioral/STAR

Past Experience