Regulatory Affairs 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
People can only live their healthiest lives on a healthy planet. Medtronic drives climate action within our operations, supply chain and industry; reduce our environmental footprint; and build our products to be more sustainable. Medtronic is committed to set near-term science-based emission reduction targets and long-term net-zero targets.

To support our Quality and Regulatory Compliance activities in the Nordic countries we are currently looking for a fulltime Regulatory Affairs Specialist. This is a great opportunity to be onboarded to our experienced Regulatory Affairs (RA) Nordic team, where you will support and advice the sales teams to assure compliance with local Nordic legislation applicable to Post Market Surveillance as well as competent authority and customer engagement. Here you can showcase your excellent communication skills and enjoy supporting the commercial business units with your advice and guidance.

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

* Monitor and interpret regulatory requirements for the Nordic countries, ensuring updates are implemented in compliance with regulatory standards
* Coordinate and support Field Safety Corrective Actions (FSCAs), working with sales teams and the FCA Support Team to ensure timely completion
* Manage and respond to inquiries from Competent Authorities, including maintaining accurate regulatory records and reporting
* Provide guidance to sales teams on product complaint handling and returns to ensure compliance with regulations and internal procedures
* Manage regulatory documentation requests from customers, tender teams, and internal stakeholders, ensuring accurate and timely responses
* Coordinate requests with relevant internal teams and ensure appropriate follow-up and resolution
* Supporting Quality & Regulatory activities within the Nordic countries, related to the certified Quality Management System (according to EN ISO 13485:2016) of the Nordic Region, i.e. Supplier Management, Distributor Management, Document Control, Key Performance Indicators (KPI) monitoring and follow up on new regulations.

Required Knowledge and Experience:

* Degree in Engineering, Life-sciences, Biology or other relevant advanced degree and at least 2 years experience
* Fluency in English and Danish, additional Nordic languages would be advantage
* Strong computer skills, including Microsoft Office (especially Excel) and the ability to work with internal systems
* Strong analytical, problem-solving, communication and organizational skills
* Ability to work independently and manage multiple tasks effectively
* Detail-oriented with a strong focus on quality and patient safety
* Integrity and accountability in all your work

Adaptability in a multicultural environment as well as the ability to complete tasks autonomously with a proactive working style is a clear advantage as is a having a curious and result-oriented personality and a focus on quality orientation & patient safety.

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.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Denmark: 560,000.00 DKK - 840,000.00 DKK |
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