Regulatory Affairs Professional
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Ballerup
WE ARE Ambu!
Millions of patients and users worldwide rely on the functionality and performance of our products. Therefore, our focus has always been to improve patient safety through the production of high-quality disposable products and their continuous development. We are a leading medical technology company with ambitious goals and a modern corporate culture. It is clear to us that our success depends to a large extent on engaged team members, who feel comfortable and enjoy coming to work every day. What makes us special is our openness, flexibility and team spirit. We are an internationally operating company, with offices and factories worldwide.
Our headquarters are located in Denmark. We work closely with each other, exchange ideas regularly and place great emphasis on transparency and collaboration. We believe this is key to innovation, creativity and success. If you want to work in a fast growing, international company where you can make a difference with your efforts, you should pay attention to the following job posting. To strengthen our team within Corporate Regulatory Affairs, Visualization, we are looking for a:
Regulatory Affairs Professional
Our promise:
As our Regulatory Affairs Professional:
Your primary focus needs to be on reporting of vigilance cases, within the Ambu- and legislative timelines. You will be the process owner of our vigilance procedures and will need to ensure that vigilance procedures always comply with the relevant regulatory requirements. Your impact will go beyond department lines because you will participate in several cross organizational post market assignments.
Regarding authority, you will have the mandate to conclude on reportability of complaints. Submit vigilance reports and communicate with competent authorities about incidents. Communicate to BSI and Ambu sales territories about reportable incidents. Review, approve or reject documents and document changes in relation to design change orders. And set regulatory requirements for these design changes.
Your areas of responsibility:
Pragmatic Regulatory Affairs Professional with good communication skills.
Preferable you have 2+ years of experience within a relevant position in the medical device industry. To succeed and excel in this role, you will need to be collaborative, show a structured approach, are equipped with a proactive, can-do mentality and have an eye for the detail while keeping the overview of the bigger picture.
Like a true Sherlock Holmes we will need you to be curious, factual and be able and comfortable to navigate our organization and its people. Given the international environment of Ambu, English is our corporate language. You will frequently use English in your daily work, which requires a high level of English language proficiency.
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 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 the Head of Regulatory Affairs Visualization, Kristine Rasmussen on +45 7225 2222.
Your application will be treated confidentially.
Millions of patients and users worldwide rely on the functionality and performance of our products. Therefore, our focus has always been to improve patient safety through the production of high-quality disposable products and their continuous development. We are a leading medical technology company with ambitious goals and a modern corporate culture. It is clear to us that our success depends to a large extent on engaged team members, who feel comfortable and enjoy coming to work every day. What makes us special is our openness, flexibility and team spirit. We are an internationally operating company, with offices and factories worldwide.
Our headquarters are located in Denmark. We work closely with each other, exchange ideas regularly and place great emphasis on transparency and collaboration. We believe this is key to innovation, creativity and success. If you want to work in a fast growing, international company where you can make a difference with your efforts, you should pay attention to the following job posting. To strengthen our team within Corporate Regulatory Affairs, Visualization, we are looking for a:
Regulatory Affairs Professional
Our promise:
- The chance to actively help shape a paradigm shift in the healthcare market
- An exciting, varied job with innovative, groundbreaking medical products
- A cooperative and friendly working atmosphere in a constantly growing, globally active company
- Being part of a dynamic team with short communication channels
- Remuneration in line with the market, and the ability to perform in a modern workplace
- The opportunity for personal and professional development.
As our Regulatory Affairs Professional:
Your primary focus needs to be on reporting of vigilance cases, within the Ambu- and legislative timelines. You will be the process owner of our vigilance procedures and will need to ensure that vigilance procedures always comply with the relevant regulatory requirements. Your impact will go beyond department lines because you will participate in several cross organizational post market assignments.
Regarding authority, you will have the mandate to conclude on reportability of complaints. Submit vigilance reports and communicate with competent authorities about incidents. Communicate to BSI and Ambu sales territories about reportable incidents. Review, approve or reject documents and document changes in relation to design change orders. And set regulatory requirements for these design changes.
Your areas of responsibility:
- Ensure regulatory compliance with regulatory requirements for medical device reporting by contributing to ongoing monitoring of relevant legislation and incorporating requirements in Ambu procedures.
- Evaluation of complaints for reportability and lead handling of vigilance cases across the organization to ensure timely reporting.
- Vigilance evaluation of Corrective Actions raised on marketed medical devices.
- Communication and interaction with Notified Body, competent authorities, and other regulatory authorities both in relation to vigilance reporting and other post market matters.
- Participate in audits/inspections as subject matter expert on vigilance. Continued improvements of vigilance work processes and procedures
- Contribute to ensure updated knowledge on regulatory requirements in general and to the incorporation of these requirements in Ambu procedures
- Maintenance of technical files on Ambu medical devices, including change order process for existing products and corporate support to RA colleagues on sites
Pragmatic Regulatory Affairs Professional with good communication skills.
Preferable you have 2+ years of experience within a relevant position in the medical device industry. To succeed and excel in this role, you will need to be collaborative, show a structured approach, are equipped with a proactive, can-do mentality and have an eye for the detail while keeping the overview of the bigger picture.
Like a true Sherlock Holmes we will need you to be curious, factual and be able and comfortable to navigate our organization and its people. Given the international environment of Ambu, English is our corporate language. You will frequently use English in your daily work, which requires a high level of English language proficiency.
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 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 the Head of Regulatory Affairs Visualization, Kristine Rasmussen on +45 7225 2222.
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 7.12.2022, 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.
- Apoteker
- Ballerup
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