Associate Regulatory Specialist

Descripción del puesto:

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 company inspiring the extraordinary, for more than 70 years, we have led the way with purpose-driven healthcare technology. That history compels us to relentlessly pursue therapies that change lives.
The role is opened to continue our daily milestone in serving our patients & partners and give them the highest level of support & partnership which is aligned with our daily mission to alleviate pain, restore health, and extend life.

In this vital role you will be responsible for the execution of regulatory activities in compliance with Medtronic standards and national regulatory requirements for Serbia, North Macedonia and Montenegro.

Responsibilities may include the following and other duties may be assigned:
* Collaborate with global and regional teams to develop and execute submission plans aligned with business priorities.
* Prepare and quality check documentation packages required for registrations, renewals and changes.
* Support regulatory requirements needed for importation activities and tender submissions.
* Oversee the execution of post marketing activities including Field Safety Corrective Actions (FSCAs) and vigilance reporting in collaboration with global teams.
* Prepare and submit Periodic Safety Updates Reports (PSURs) to Competent authorities.
* Maintain effective communication and ongoing follow up with external agencies and different stakeholders.
* Keeps abreast of regulatory procedures and changes affecting business and proactively communicate updates to relevant stakeholders.
* Monitors and improves internal tracking / control systems.

Required Knowledge and Experience:
* Bachelor's degree, Pharmaceutical/Medical/ Science background.
* 1-2 years of related regulatory experience.
* Good command of English both verbal and written.
* Organizational skills.
* Good communication skills.
* Self-motivated, proactive & dynamic.

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