Regulatory Affairs Specialist

Beschreibung:

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.

The Regulatory Affairs Specialist will oversee products regulatory activities for Albania, Bosnia & Herzegovina, Croatia, Kosovo and Slovenia to ensure complying with international and local regulations. This role involves planning, execution, and coordination with regulatory bodies, internal and external stakeholders for new products introduction and maintenance of existing ones.

Responsibilities may include the following and other duties may be assigned:
* Collaborate with global / regional teams to build and maintain a submission plan for new launches, renewals and changes according to business strategy and establish mechanisms for tracking progress against set Key Performance Indicators (KPIs).
* Collaborate with global teams and external partners (e.g. distributors) on sourcing & quality check of documents packages required for new registrations, renewals, changes and notifications submissions.
* Support regulatory requirements needed for importation and tender submissions.
* Manage Medical Device Directive (MDD) / Medical Device Regulation (MDR) Transition plan.
* Collaborate with global teams on post marketing vigilance activities execution including Field Safety Corrective Actions (FSCAs).
* Keep abreast of regulatory procedures and changes.
* Interact with competent authorities and other external stakeholders.
* Maintain tracking / control systems.

Required Knowledge and Experience:
* Bachelor's or Master's degree in Medicine, Pharmacy, Bioengineering, Chemistry or related field.
* Minimum of 2 years of relevant experience in regulatory affairs preferably in medical devices field.
* Fluent English (spoken and written); mandatory proficiency in Slovenian; Croatian knowledge an advantage.
* Highly motivated, strong customer focus.
* Good organizational skills.
* Good communication skills.
* Positive team spirit.

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