id: NDk2ODI2OSA3

reference: 4968269

documentId: 4968269

connectionPointId: 7

lastModificationDate: 1554208273560

stillingsbetegnelse:
Pharmacist, Engineer or Cand.Scient for Regulatory Affairs, Vigilance within Medical Devices

jobbeskrivelse:

Description

In the Regulatory Affairs Vigilance team, we collaborate with our colleagues to ensure that our products offer reliable, fast and easy patient diagnoses. Our job is to communicate with health authorities on adverse events and other important events related to our products. This includes information on what caused the events and what the potential problem is, while ensuring timely notification of the authorities about our field actions worldwide. 

We combine our ability of understanding health authorities’ legislation with structuring processes, creating efficient Standard Operating Procedures (SOPs) and asking the right questions to gather the information needed from our stakeholders throughout the organization.

 

Welcome to Regulatory Affairs in Radiometer Medical

The entire RA team consists of approximately 40 employees where the majority of the team is located in our HQ in Brønshøj / Copenhagen. You join, Senior Manager, RA, Kristina Olsson’s vigilance team and will become the 4th team member referring to Kristina. She explains the following about the team:

“Our work environment is really unique. Things are busy and we get things done, but we always focus on the quality of our work, the products and the way we collaborate. People are open and friendly when engaging in dialogue to share the valuable information we need. This is the case whether we are talking with our Regulatory Affairs colleagues or our collaboration partners in e.g. R&D, Sales, Marketing or the Production.

Curiosity, structure, respectful communication, global mindset and focus on keeping deadlines are key words for you to succeed in Regulatory Affairs.

 

Your responsibilities

• Ensuring timely reporting of adverse events and field actions worldwide

• Working in cross-functional projects/tasks

• Legislation monitoring and being able to translate and implement this in Radiometer

• Participate in process improvements and creation of SOPs in the RA area 

That way you contribute to keeping Radiometer’s products in compliance and help us reach important milestones that ensure our products can safely be used for fast and reliable patient diagnoses all over the world.

 

We offer you

A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development, and a wide range of staff benefits.

 

Application deadline

Application deadline is 22 April 2019. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents. We look forward to receiving your application.

For further information, please contact Senior Manager, RA, Kristina Olsson, at tel. +45 2795 0451.

 

Qualifications 

Desire to work in Regulatory Affairs and qualifications

The preferred candidate holds a Master Degree in Science, Engineering, Pharmacy, Biology, Biochemistry or the like.

 

Competencies / Skills / Experiences that will give you a head start in this role

• Preferably, experience with the medical device and/or in-vitro diagnostic legislation.

• Preferably, experienced in working with vigilance and having cross functional interactions.

• Experienced in communication with regulatory authorities.

• Experienced in effective national and international communication.

• Preferably experience with process improvements.

• Experience in working independently and ability to deliver within tight deadlines.

 

Language

• The preferred Candidate is fluent in English both in writing and verbally.

 

IT

• Experienced MS Office (Excel, PowerPoint, Word, and Outlook) user and familiar working in databases e.g. DocuNote.

 Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. 

Organization:  Radiometer
Job Function:  Quality and Regulatory Affairs
Primary Location:  EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule:  Full-time

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2131

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: RADIOMETER MEDICAL ApS

source: DK-STAR