Senior Vigilance Specialist
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Are you the go-to person when it comes to reporting requirements for medical devices? Would you like to play a key role in maintaining Ambu’s continuous regulatory compliance by being responsible for the vigilance process? And are you looking for a job with many international stakeholders? Then Ambu might be your next career move…
Ambu is a global company with ambitious growth targets and an exciting and growing product portfolio. Our ability to identify and adapt to the evolving regulatory landscape is essential for continuous growth within our business areas. Therefore, Ambu is looking for a Senior Vigilance Specialist to take part in ensuring continuous compliance for vigilance reporting. As a Senior Vigilance Specialist, you will become part of a team, which consists of employees from Denmark, Germany, USA, China and Malaysia, with whom you will work closely.
Ensure company compliance with regulatory requirements.
As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of the vigilance process and set the strategic direction and framework for us to comply with the different regulations. You have a profound and holistic overview of the regulatory requirements for reporting and put it into practice by empowering peers involved in the vigilance process. This is done by acting as the vigilance go-to person in the organization e.g. for guidance, review and decision making in relation to reportability, process improvements and by knowledge sharing and communication of reporting requirements e.g. by chairing workshops and facilitating internal training. You show the way by delivering best-practice solutions. Communication and process understanding is therefore a key part of your assignments.
Your primary responsibilities will be to Act as Process responsible for the Vigilance Process by:
You will join the Corporate Regulatory Affairs department within the RA Operation team, but you will work with the rest of the Corporate Regulatory Affair department 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 a requirement that you have minimum 4+ 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 and knowledge of regulatory roles and responsibilities in partnerships across jurisdictions. Experience working with vigilance, post-market surveillance, ISO 13485 including MDSAP requirements 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 share your knowledge and take lead of the vigilance process. In addition, you must have an analytical and structured approach to your work and the capacity to priorities 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 we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 22nd of August 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.
#LI_AM1
Ambu is a global company with ambitious growth targets and an exciting and growing product portfolio. Our ability to identify and adapt to the evolving regulatory landscape is essential for continuous growth within our business areas. Therefore, Ambu is looking for a Senior Vigilance Specialist to take part in ensuring continuous compliance for vigilance reporting. As a Senior Vigilance Specialist, you will become part of a team, which consists of employees from Denmark, Germany, USA, China and Malaysia, with whom you will work closely.
Ensure company compliance with regulatory requirements.
As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of the vigilance process and set the strategic direction and framework for us to comply with the different regulations. You have a profound and holistic overview of the regulatory requirements for reporting and put it into practice by empowering peers involved in the vigilance process. This is done by acting as the vigilance go-to person in the organization e.g. for guidance, review and decision making in relation to reportability, process improvements and by knowledge sharing and communication of reporting requirements e.g. by chairing workshops and facilitating internal training. You show the way by delivering best-practice solutions. Communication and process understanding is therefore a key part of your assignments.
Your primary responsibilities will be to Act as Process responsible for the Vigilance Process by:
- Lead and coordinate the handling of vigilance cases, including the organizational coordination of vigilance investigations with colleagues in various parts of Ambu and external partners
- Ensure Ambu successfully implements new legislation for vigilance requirements by setting the strategic direction and framework
- Facilitate training, knowledge sharing and alignment in relation to reporting requirements
- Ensure professional communication and timely reporting of vigilance reports to authorities
- Handle and coordinate daily evaluation of complaints for reportability
- Participate in CA’s raised for products on the market
- Coordination, communication and 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) and empower company and process decisions
- Participate as Ambu vigilance subject matter expert in inspections and audits
You will join the Corporate Regulatory Affairs department within the RA Operation team, but you will work with the rest of the Corporate Regulatory Affair department 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 a requirement that you have minimum 4+ 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 and knowledge of regulatory roles and responsibilities in partnerships across jurisdictions. Experience working with vigilance, post-market surveillance, ISO 13485 including MDSAP requirements 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 share your knowledge and take lead of the vigilance process. In addition, you must have an analytical and structured approach to your work and the capacity to priorities 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 we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 22nd of August 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.
#LI_AM1
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 16.7.2021, 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.
- Øvrige
- Ballerup
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