Regulatory Affairs Professional
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Do you enjoy working with regulations and documentation? And are you ready to take responsibility, compile documentation and ensure regulatory requirements are complied with for Ambu’s medical devices? Then you might be the RA Professional Ambu is looking for.
Ensure company compliance with reporting requirements
In this position, you will play an important role in ensuring regulatory support and compliance to a wide range of lifecycle activities. Your primary tasks will be to handle various lifecycle activities for a range of Ambu’s marketed products within the patient monitoring and anesthesia portfolio e.g., electrodes and manikins. You will handle these tasks in cooperation with regulatory partners at our manufacturing sites in China and Malaysia. You will also support other post market activities such as daily evaluation of complaints for reportability.
You can dive into regulations and create an overview of the regulatory requirements and put it into practice by decision making and compilation of documentation. Communication, audit participation and process understanding are therefore a vital part of your responsibility. You will become part of a team handling various regulatory lifecycle activities and will be expected to chip in on other tasks when needed or in case of spare time – this could for example be process updates.
As RA Professional your primary responsibilities will be:
• Participate in maintenance of technical files for marketed products and provide regulatory support for product changes
• Corporate support and sparring to local regulatory affairs departments at our manufacturing and innovation sites
• Daily evaluation of complaints for reportability
You will join the Corporate Regulatory Affairs department within the RA Operation team, but you will work with the rest of Regulatory Affairs and with the QA-Engineering department, local Regulatory Affairs and QA departments at our manufacturing sites, Clinical, Marketing, and other departments.
Pro-active and positive professional with good communication skills
It is preferable that you have 2+ years of experience within a relevant position in the medical device industry. It will be an advantage that you have a global outlook regarding device legislation. Experience working with medical device legislation, ISO 13485 and risk management will be a plus. In terms of education, you must hold either a bachelor’s or a Masters’ degree in the field of science.
You can find solutions by taking a deep dive into regulations and guidelines when needed. To support decision making, you can communicate requirements and solutions in a clear matter and can navigate many agendas and stakeholders. We want you to seek and share knowledge. In addition, you must have an analytical and structured approach to your work and the capacity to prioritize to meet deadlines.
Ambu – a visionary and international workplace where your efforts matter
As Ambu is a global company it is essential that you have excellent English skills and that you have a global mindset in relation to both co-workers and business opportunities.
We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.
When to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate.
For further inquiries please contact, Head of Regulatory Affairs Operation, Katrine Dalsgaard Ajbro, at +45 26779750.
Your application will be treated confidentially.
Ensure company compliance with reporting requirements
In this position, you will play an important role in ensuring regulatory support and compliance to a wide range of lifecycle activities. Your primary tasks will be to handle various lifecycle activities for a range of Ambu’s marketed products within the patient monitoring and anesthesia portfolio e.g., electrodes and manikins. You will handle these tasks in cooperation with regulatory partners at our manufacturing sites in China and Malaysia. You will also support other post market activities such as daily evaluation of complaints for reportability.
You can dive into regulations and create an overview of the regulatory requirements and put it into practice by decision making and compilation of documentation. Communication, audit participation and process understanding are therefore a vital part of your responsibility. You will become part of a team handling various regulatory lifecycle activities and will be expected to chip in on other tasks when needed or in case of spare time – this could for example be process updates.
As RA Professional your primary responsibilities will be:
• Participate in maintenance of technical files for marketed products and provide regulatory support for product changes
• Corporate support and sparring to local regulatory affairs departments at our manufacturing and innovation sites
• Daily evaluation of complaints for reportability
You will join the Corporate Regulatory Affairs department within the RA Operation team, but you will work with the rest of Regulatory Affairs and with the QA-Engineering department, local Regulatory Affairs and QA departments at our manufacturing sites, Clinical, Marketing, and other departments.
Pro-active and positive professional with good communication skills
It is preferable that you have 2+ years of experience within a relevant position in the medical device industry. It will be an advantage that you have a global outlook regarding device legislation. Experience working with medical device legislation, ISO 13485 and risk management will be a plus. In terms of education, you must hold either a bachelor’s or a Masters’ degree in the field of science.
You can find solutions by taking a deep dive into regulations and guidelines when needed. To support decision making, you can communicate requirements and solutions in a clear matter and can navigate many agendas and stakeholders. We want you to seek and share knowledge. In addition, you must have an analytical and structured approach to your work and the capacity to prioritize to meet deadlines.
Ambu – a visionary and international workplace where your efforts matter
As Ambu is a global company it is essential that you have excellent English skills and that you have a global mindset in relation to both co-workers and business opportunities.
We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.
When to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate.
For further inquiries please contact, Head of Regulatory Affairs Operation, Katrine Dalsgaard Ajbro, at +45 26779750.
Your application will be treated confidentially.
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 16.12.2022, 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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