Regulatory Affairs Professional
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Regulatory Affairs Professional - Specialized in vigilance reporting
Do you enjoy working with complex cases, documentation and communication with authorities? And are you ready to take responsibility, compile high quality authority reports and ensure reporting deadlines are complied with for our 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 a wide range of activities related to vigilance reporting in the post market phase. Taking part in improving the process and setting a high standard for vigilance reporting will be a natural part of the job.
You can dive into regulations and create an overview of the regulatory requirements for reporting and put it into practice by decision making in relation to reportability and timely delivery of high-quality reports. 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 e.g. be review tasks in relation to product changes.
Your primary responsibilities will be to execute within the Vigilance Process by:
- Timely reporting of vigilance reports to authorities (e.g. compilation of reports, communication with authorities, coordination of investigations with colleagues in various parts of Ambu and external partners)
- Take part in implementation and communication of new vigilance requirements
- Daily evaluation of complaints for reportability
- CA support and reporting incl. record keeping in case of Field Safety Corrective Actions
- Provide guidance to the organization on vigilance and cooperate with interfacing processes (such as complaint handling, CAPA, clinical, risk management, PMS etc)
- Participate as Ambu vigilance subject matter expert in inspections and audits
- 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
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 vigilance, post market surveillance, 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 in order to meet deadlines.
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 candidates will be invited for interviews on a continuous basis so no need to hesitate. This job ad might be online until 22nd of November 2021 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.
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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 7.5.2021, 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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