QA Specialist
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Ballerup
QA specialist, MDR, Vigilance and Recall Reporting – improve our handling of potential reportable complaints and MDR/Vigilance reporting processes
Do you want to ensure safe and enriching sound experiences by managing our customer complaint and vigilance reporting processes internationally?
“You will play an important role in our work to improve our way of assessing reportability of complaints to National Competent Authorities, securing on-time decision and documentation” says, Post Market Surveillance and Vigilance Team Lead, Iwona Maria Jensen
Welcome to the Post Market Surveillance and Vigilance team
Our team is part of Corporate Quality within GN Hearing, and our specialists have one steady focus: Securing that our products are safe for our patients. At our HQ in Ballerup, we work with post market surveillance data gathered from end-users, hearing care professionals, authorities, and other corporate function within GN Hearing.
What will you do?
As our QA specialist your core responsibility will be supporting the team and its stakeholders with reportability decision of potential reportable complaints and reporting those, which are required, to the relevant authorities. You will keep yourself up to date with the regulatory requirements and secure that our process follow the latest requirements. In addition, you will take part in the Post Market Surveillance activities and will act as a regulatory specialist for other functions to ensure regulatory compliance within the field of Post Market Surveillance, MDR, Vigilance and Recall.
More specifically, you will:
If you want to know more about the position, you are welcome to contact Post Market Surveillance and Vigilance Team Lead, Iwona Maria Jensen on +45 24791357.
Do you want to ensure safe and enriching sound experiences by managing our customer complaint and vigilance reporting processes internationally?
“You will play an important role in our work to improve our way of assessing reportability of complaints to National Competent Authorities, securing on-time decision and documentation” says, Post Market Surveillance and Vigilance Team Lead, Iwona Maria Jensen
Welcome to the Post Market Surveillance and Vigilance team
Our team is part of Corporate Quality within GN Hearing, and our specialists have one steady focus: Securing that our products are safe for our patients. At our HQ in Ballerup, we work with post market surveillance data gathered from end-users, hearing care professionals, authorities, and other corporate function within GN Hearing.
What will you do?
As our QA specialist your core responsibility will be supporting the team and its stakeholders with reportability decision of potential reportable complaints and reporting those, which are required, to the relevant authorities. You will keep yourself up to date with the regulatory requirements and secure that our process follow the latest requirements. In addition, you will take part in the Post Market Surveillance activities and will act as a regulatory specialist for other functions to ensure regulatory compliance within the field of Post Market Surveillance, MDR, Vigilance and Recall.
More specifically, you will:
- Initiate and drive potential MDR, Vigilance and Recall investigations to conclusion and prepare and file necessary MDR, Vigilance, Recall reports, supported by relevant SMEs
- Work closely with other corporate functions including Audiology and R&D with the aim of constant improvement of our investigation and reporting process
- Provide guidance on clinical evaluation and/or technical functionality as part of the decision process
- Provide input to Post Market Surveillance Review Meetings on MDR, Vigilance and Recall activities
- Monitor authorities through the Country Medical Device Reporting databases for incoming adverse events from our competitors
- Train and keep our organization updated on regulatory requirements, systems, processes, and tools both on site and via TeamsHighly analytical with quality assurance experience
Preferably you hold an audiology degree or have clinical experience from the field, or you might have another technical background enabling good understanding of the functionality of our products and its intended use. You are very organized and have a great sense of details. You have analytical skills which help you seeing the greater picture and connecting the dots. You have good communication skills and can form productive working relations across different functions and cultures.
- You have at least 2 years’ experience in quality assurance and risk management, including MDR, Vigilance and Recall handling within the medical device, pharmaceutical or a similarly regulated industry
- You can read, understand, and implement regulatory requirements as part of the processes
- You are preferably trained in medical device standards, ISO 13485, QSR and MDR 2017/745
- You can travel up to 10 days a year
- You are fluent in English and capable of writing reports in an appropriate academic language It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our stakeholders a positive experience.
Would you like to know more?
To apply, use the ‘APPLY’ link no later than September 20th, 2020. Applications are assessed on a continuous basis, which is why we encourage you to send your application as soon as possible.
If you want to know more about the position, you are welcome to contact Post Market Surveillance and Vigilance Team Lead, Iwona Maria Jensen on +45 24791357.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 1.9.2020, 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.
- Produktspecialist
- Ballerup
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Statistik over udbudte jobs som produktspecialister i Ballerup
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Statistik over udbudte produktspecialister i Ballerup over tid
| Dato | Alle jobs som produktspecialister |
|---|---|
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| 25. november 2024 | 4 |
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| 23. november 2024 | 6 |
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| 31. oktober 2024 | 11 |
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| 28. oktober 2024 | 11 |
| 27. oktober 2024 | 11 |