QA/RA Specialist
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Ballerup
Ambu develops, manufactures and sells medical devices. Millions of patients and healthcare professionals depend on the functionality and performance of Ambu’s products worldwide.
As our new QA/RA Specialist, you will be working in the Sales Territory Nordic and Emerging Markets team (ST NEM) which is responsible for sales to the Nordic area and other distributor markets in Europe, Russia and the Middle East. We are located in
Ambu’s headquarters in Ballerup. You will report directly to the Customer Service Manager and you will join a highly motivated and well-functioning team.
Regulatory, Quality and Compliance
You will have an exciting and independent job where you will take the lead and ownership of registrations, quality and compliance tasks for the sales territory. This is a newly established position with means that you will have a great deal of influence on the set-up and in forming the position.
Your primary areas of responsibility will be to:
Act as point of contact for Market Authorisation Holder (MAH) and Global QA/RA regarding national registration and Vigilance assistance within the ST NEM area. This includes implementing processes to secure local quality demands, coordinating surveillance of the regulatory regulations and landscape and coordinating national registrations and vigilance etc. Act as second level support for RA Specialist based in Russia Ensure quality assurance within the ST NEM territory Handle, assure and own the ST NEM documentation archive
You will have daily contact with your colleagues in the sales territory and close cooperation with the corporate QA/RA representatives.
We are committed to work in an informal and pleasant working environment where collaboration, freedom with responsibility and humour are key in our everyday lives.
Experience with QA/RA for medical devices
To be successful in the job, it is vital to us that you have experience with national medical device regulation, registration requirements and national certification requirements. You must be able to read, interpret and understand the technical parts of national product specific standards and you must be able to provide intelligence to corporate functions when deemed appropriate. It is also important that you are familiar with the specific requirements on Medical Device classification, labelling and vigilance within the major markets of the territory.
It is expected that you hold a master’s degree within the field of various sciences or health disciplines such as engineer, veterinarian, molecular or human biologist.
As a person, you are of course structured and organized but you are also patient. You are able to juggle many cases and you have excellent communication skills and are able to talk with many different stakeholders from different cultures.
As we care for our working environment, it is also important for us that you are a team-player and like to cooperate.
Due to the nature of the task it is also a requirement that you speak and write fluent English on a business level and that you have knowledge of one or more Nordic languages.
Ambu – an ambitious & professional workplace
Ambu is a company with ambitious growth objectives and we are very focused on developing and putting innovative products to market. We reach our objectives through interdisciplinary collaboration between motivated and competent colleagues in an informal work environment. Our rapid development means that there is a natural focus on the ongoing development of your professional and personal skills that will help to ensure Ambu's continued success.
We offer a wide range of professional, social and economic benefits, in addition to the exciting challenges of the job.
When to apply
If you are ready to apply for the position, please apply as soon as possible and no later than 26 August 2019.
Your application will, of course, be treated confidentially.
You can obtain additional information about the job and about Ambu A/S by contacting Customer Service Manager Bente Ejrup, telephone no. +45 7225 2000.
As our new QA/RA Specialist, you will be working in the Sales Territory Nordic and Emerging Markets team (ST NEM) which is responsible for sales to the Nordic area and other distributor markets in Europe, Russia and the Middle East. We are located in
Ambu’s headquarters in Ballerup. You will report directly to the Customer Service Manager and you will join a highly motivated and well-functioning team.
Regulatory, Quality and Compliance
You will have an exciting and independent job where you will take the lead and ownership of registrations, quality and compliance tasks for the sales territory. This is a newly established position with means that you will have a great deal of influence on the set-up and in forming the position.
Your primary areas of responsibility will be to:
You will have daily contact with your colleagues in the sales territory and close cooperation with the corporate QA/RA representatives.
We are committed to work in an informal and pleasant working environment where collaboration, freedom with responsibility and humour are key in our everyday lives.
Experience with QA/RA for medical devices
To be successful in the job, it is vital to us that you have experience with national medical device regulation, registration requirements and national certification requirements. You must be able to read, interpret and understand the technical parts of national product specific standards and you must be able to provide intelligence to corporate functions when deemed appropriate. It is also important that you are familiar with the specific requirements on Medical Device classification, labelling and vigilance within the major markets of the territory.
It is expected that you hold a master’s degree within the field of various sciences or health disciplines such as engineer, veterinarian, molecular or human biologist.
As a person, you are of course structured and organized but you are also patient. You are able to juggle many cases and you have excellent communication skills and are able to talk with many different stakeholders from different cultures.
As we care for our working environment, it is also important for us that you are a team-player and like to cooperate.
Due to the nature of the task it is also a requirement that you speak and write fluent English on a business level and that you have knowledge of one or more Nordic languages.
Ambu – an ambitious & professional workplace
Ambu is a company with ambitious growth objectives and we are very focused on developing and putting innovative products to market. We reach our objectives through interdisciplinary collaboration between motivated and competent colleagues in an informal work environment. Our rapid development means that there is a natural focus on the ongoing development of your professional and personal skills that will help to ensure Ambu's continued success.
We offer a wide range of professional, social and economic benefits, in addition to the exciting challenges of the job.
When to apply
If you are ready to apply for the position, please apply as soon as possible and no later than 26 August 2019.
Your application will, of course, be treated confidentially.
You can obtain additional information about the job and about Ambu A/S by contacting Customer Service Manager Bente Ejrup, telephone no. +45 7225 2000.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 31.7.2019, 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.
- Produktspecialist
- Ballerup
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