Pharmacist, Engineer or Cand.Scient for Regulatory Affairs, Vigilance within Medical De...
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Brønshøj
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
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.
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
Language
IT
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 12 January 2020. 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 on Tuesdays, at tel. +45 2795 0451.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
Kilde: Jobnet.dk
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.
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.
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 12 January 2020. 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 on Tuesdays, at tel. +45 2795 0451.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Brønshøj.
Jobbet er oprettet på vores service den 2.1.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Brønshøj
- Søndag den 12. januar 2020
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