Senior Regulatory Affairs Professional with strong skills in software regulation
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Are you looking for independence in your job and a working day characterised by exciting new challenges? Would you like to be part of Ambu’s new product development teams and ensure that we meet regulatory requirements related to software in an agile way? Then Ambu might be your next career move…
Ambu is a global company with ambitious growth targets. Our ability to identify and develop innovative products is essential for continuous growth within our business areas. To be able to meet the increasing regulatory requirements on time, Ambu is looking for a skilled candidate to join the Corporate Regulatory Affairs department within our RA Innovation team. You will be an extension to a rapidly growing team as we have an ambitious plan to develop 30 new products during the next couple of years, you will get lots of opportunities to develop in your new role.
Implementing agile regulatory strategies for medical device software
As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of new products within regulatory affairs in a company where quality is of great importance. Here you will be responsible for implementing regulatory strategies and providing regulatory input for our visualization devices containing software.
Your primary responsibilities will be related to the regulatory framework for software development:
• Defining agile regulatory strategies for medical device software to ensure a fast-to-market approach.
• Be fully updated on regulatory requirements and guidance for medical device software.
• Provide regulatory input regarding software to technology tracks and innovation projects.
You will be part of both technology tracks looking into technologies across our product portfolio and of innovation projects focusing on the development of new innovative devices. Being part of cross functional teams you will be working closely together with stakeholders from QA-Engineering, R&D, Marketing, Clinical Department and other departments to develop our new products.
Assertive Senior RA professional with good communication skills
You hold a master’s degree in computer science, engineering or other relevant education and you have experience working with software in a regulated industry, preferably the medical device industry. Knowledge of relevant legislation and standards such as EN 62304 Medical device software – Software life-cycle processes and EN 60601 Medical electrical equipment will be an advantage.
To succeed in the job, you have a strategic mindset, are proactive able and a teamplayer. Furthermore, you must hold good 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 25 of October 2020 but once we have found the right candidate, this ad will no longer be online.
If you have any questions about the position, you can contact Kristine Rasmussen, Head of RA Innovation, by phone +45 51810901
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
Ambu is a global company with ambitious growth targets. Our ability to identify and develop innovative products is essential for continuous growth within our business areas. To be able to meet the increasing regulatory requirements on time, Ambu is looking for a skilled candidate to join the Corporate Regulatory Affairs department within our RA Innovation team. You will be an extension to a rapidly growing team as we have an ambitious plan to develop 30 new products during the next couple of years, you will get lots of opportunities to develop in your new role.
Implementing agile regulatory strategies for medical device software
As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of new products within regulatory affairs in a company where quality is of great importance. Here you will be responsible for implementing regulatory strategies and providing regulatory input for our visualization devices containing software.
Your primary responsibilities will be related to the regulatory framework for software development:
• Defining agile regulatory strategies for medical device software to ensure a fast-to-market approach.
• Be fully updated on regulatory requirements and guidance for medical device software.
• Provide regulatory input regarding software to technology tracks and innovation projects.
You will be part of both technology tracks looking into technologies across our product portfolio and of innovation projects focusing on the development of new innovative devices. Being part of cross functional teams you will be working closely together with stakeholders from QA-Engineering, R&D, Marketing, Clinical Department and other departments to develop our new products.
Assertive Senior RA professional with good communication skills
You hold a master’s degree in computer science, engineering or other relevant education and you have experience working with software in a regulated industry, preferably the medical device industry. Knowledge of relevant legislation and standards such as EN 62304 Medical device software – Software life-cycle processes and EN 60601 Medical electrical equipment will be an advantage.
To succeed in the job, you have a strategic mindset, are proactive able and a teamplayer. Furthermore, you must hold good 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 25 of October 2020 but once we have found the right candidate, this ad will no longer be online.
If you have any questions about the position, you can contact Kristine Rasmussen, Head of RA Innovation, by phone +45 51810901
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 25.9.2020, 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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