Regulatory Affairs Professional
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- compliance is the keyword!
Are you looking for independence in your job and a working day characterised by exciting new challenges? Would you like to be part of maintaining Ambu’s continuous regulatory compliance of products and ensure improvement and regulatory guidance in processes related to labelling? And are you looking for an international job? Then Ambu might be your next career move…
Ambu is a global company with ambitious growth targets. Our ability to identify and adapt to the evolving regulatory landscape is essential for continuous growth within our business areas. To be able to meet the increasing regulatory requirements on time and in a correct manner, Ambu is looking for a skilled candidate to join the Corporate Regulatory Affairs department.
As a Regulatory Affairs Professional, you will become part of a team, which consists of employees from Denmark, Germany, USA, China and Malaysia, with whom you will work closely. Corporate Regulatory Affairs is a part of Corporate QA & RA.
As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of Regulatory Affairs in a company where quality is of great importance.
Ensure company compliance with regulatory requirements
As Regulatory Affairs Professional, you will be responsible for ensuring compliance with regulatory requirements for products and processes in prioritised markets – especially related to labelling and UDI.
Your primary responsibilities will be to:
Due to a high level of collaboration with internal stakeholders, a high level of adaptability is required. You will be working closely with Corporate Marketing, QA-Engineering department, local regulatory affairs departments at our manufacturing sites, R&D, Clinical Department, Corporate Business Analysis and other departments.
Proactive and positive RA professional with good communication skills
It is a requirement that you have minimum 2-4 years of experience with Regulatory Affairs from the medical device industry and that you have experience with the EU and US legislation for medical devices. Experience working with ISO 13485, medical device labelling requirements and standards, UDI requirements and labelling of kits will be an advantage. You have the ability and interest in reviewing a new theory or law and put it into practice. In terms of education, you must hold either a bachelor’s or a Masters’ degree in the field of science.
Being curious, able to work independently, proactive in terms of gaining understanding and knowledge and able to handle requests and tasks with a positive attitude, is key to success. In addition, you turn challenges into opportunities, and you have a natural personal impact.
You must have an analytical and structured approach to your work and the capacity to prioritise in order to meet deadlines. Furthermore, you must hold excellent communication skills including speaking and writing English on a high level.
Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us, you will get the opportunity to work in an international head office with an informal working environment.
We offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.
How to apply
If you are ready to apply for the position, please apply as soon as possible. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 15 July 2020 but once we have found the right candidate, this add will no longer be online.
If you have any questions about the position, you can contact Katrine Dalsgaard Ajbro, Head of Regulatory Affairs Operation, by phone +45 26779750.
Your application will be treated with confidentiality.
About Ambu
Since 1937, breakthrough ideas have fuelled our work on bringing efficient healthcare solutions to life. This is what we create within our fields of excellence – Anaesthesia, Patient Monitoring & Diagnostics, and Emergency Care. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our products. We are dedicated to improve patient safety and determined to advance single-use devices. The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our newest landmark solutions like the Ambu aScope™ – the world’s first single-use flexible endoscope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognized medical companies in the world. Headquartered near Copenhagen in Denmark, Ambu employs approximately 3,100 people in Europe, North America and the Asia Pacific. For more information, please visit www.Ambu.com
Are you looking for independence in your job and a working day characterised by exciting new challenges? Would you like to be part of maintaining Ambu’s continuous regulatory compliance of products and ensure improvement and regulatory guidance in processes related to labelling? And are you looking for an international job? Then Ambu might be your next career move…
Ambu is a global company with ambitious growth targets. Our ability to identify and adapt to the evolving regulatory landscape is essential for continuous growth within our business areas. To be able to meet the increasing regulatory requirements on time and in a correct manner, Ambu is looking for a skilled candidate to join the Corporate Regulatory Affairs department.
As a Regulatory Affairs Professional, you will become part of a team, which consists of employees from Denmark, Germany, USA, China and Malaysia, with whom you will work closely. Corporate Regulatory Affairs is a part of Corporate QA & RA.
As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of Regulatory Affairs in a company where quality is of great importance.
Ensure company compliance with regulatory requirements
As Regulatory Affairs Professional, you will be responsible for ensuring compliance with regulatory requirements for products and processes in prioritised markets – especially related to labelling and UDI.
Your primary responsibilities will be to:
- Participate as a regulatory professional partner in activities and projects related to labelling, UDI, and master data requirements and business processes
- Contribute to that Ambu successfully implements labelling and UDI requirements from e.g. new EU and US medical device legislation
- Act as a sparring partner in regard to labelling requirements for both projects and colleagues in regulatory affairs, marketing, commercial processes etc.
- Surveillance of labelling and UDI requirements and contribute to incorporate relevant requirements in the quality system and ensuring that Ambu’s products and processes comply with relevant regulatory requirements
- Maintenance and development of Regulatory Affairs records including corporate support to local regulatory affairs departments at our manufacturing and innovation sites.
Due to a high level of collaboration with internal stakeholders, a high level of adaptability is required. You will be working closely with Corporate Marketing, QA-Engineering department, local regulatory affairs departments at our manufacturing sites, R&D, Clinical Department, Corporate Business Analysis and other departments.
Proactive and positive RA professional with good communication skills
It is a requirement that you have minimum 2-4 years of experience with Regulatory Affairs from the medical device industry and that you have experience with the EU and US legislation for medical devices. Experience working with ISO 13485, medical device labelling requirements and standards, UDI requirements and labelling of kits will be an advantage. You have the ability and interest in reviewing a new theory or law and put it into practice. In terms of education, you must hold either a bachelor’s or a Masters’ degree in the field of science.
Being curious, able to work independently, proactive in terms of gaining understanding and knowledge and able to handle requests and tasks with a positive attitude, is key to success. In addition, you turn challenges into opportunities, and you have a natural personal impact.
You must have an analytical and structured approach to your work and the capacity to prioritise in order to meet deadlines. Furthermore, you must hold excellent communication skills including speaking and writing English on a high level.
Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us, you will get the opportunity to work in an international head office with an informal working environment.
We offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.
How to apply
If you are ready to apply for the position, please apply as soon as possible. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 15 July 2020 but once we have found the right candidate, this add will no longer be online.
If you have any questions about the position, you can contact Katrine Dalsgaard Ajbro, Head of Regulatory Affairs Operation, by phone +45 26779750.
Your application will be treated with confidentiality.
About Ambu
Since 1937, breakthrough ideas have fuelled our work on bringing efficient healthcare solutions to life. This is what we create within our fields of excellence – Anaesthesia, Patient Monitoring & Diagnostics, and Emergency Care. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our products. We are dedicated to improve patient safety and determined to advance single-use devices. The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our newest landmark solutions like the Ambu aScope™ – the world’s first single-use flexible endoscope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognized medical companies in the world. Headquartered near Copenhagen in Denmark, Ambu employs approximately 3,100 people in Europe, North America and the Asia Pacific. For more information, please visit www.Ambu.com
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 3.6.2020, 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.
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