Senior Regulatory Affairs Professional
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Kongens Lyngby
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
Senior Regulatory Affairs Professional
As our new Senior Regulatory Affairs Professional, your main responsibility will be to ensure regulatory strategies for new products and changes to existing products are performed according to project plans. Further, you will have a key role in implementing the Unique Device Identification (UDI) requirements and upload data to EUDAMED, when available.
Our first product solution for monitoring and analysing brain activity (EEG) aimed at improving the lives of fellow humans, impaired by epileptic seizures is available on the European market. The product portfolio consists a sterile active implant, a sterile insertion tool and a recorder that communicates with the implant. Further, we have software products for transfer of data. The products are developed under the directives for active implantable medical devices and we are currently in transition to the European Medical Device Regulation (MDR), where the devices mainly will be of class III.
The department:
You will be joining 7 highly dedicated and skilled colleagues in the QA/RA department. You will become part of an ambitious team with an informal relation, good humour and where we take care of each other. We are open and honest and appreciate a colleague who takes responsibility and have a positive approach to new challenges.
The QA/RA department have close cooperation with different stakeholders. As UNEEG medical is a small company, the QA/RA department cover a broad range of tasks such as participating in development projects, maintaining and implementing new requirements in the quality management system, supporting manufacturing activities and market expansions.
Key responsibilities include:
Requirements:
About UNEEG medical A/S
UNEEG medical A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life. Our unique subcutaneous EEG solution for remote monitoring of brain activity was CE marked in 2019 and our continued international growth and technology roadmap ambitions will require several new functions and competencies in the years to come.
UNEEG medical A/S was founded in 2005. We currently employ approximately 100 people in Europe – the majority of these are situated in our new headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience. Read more about us at [email protected]
Senior Regulatory Affairs Professional
As our new Senior Regulatory Affairs Professional, your main responsibility will be to ensure regulatory strategies for new products and changes to existing products are performed according to project plans. Further, you will have a key role in implementing the Unique Device Identification (UDI) requirements and upload data to EUDAMED, when available.
Our first product solution for monitoring and analysing brain activity (EEG) aimed at improving the lives of fellow humans, impaired by epileptic seizures is available on the European market. The product portfolio consists a sterile active implant, a sterile insertion tool and a recorder that communicates with the implant. Further, we have software products for transfer of data. The products are developed under the directives for active implantable medical devices and we are currently in transition to the European Medical Device Regulation (MDR), where the devices mainly will be of class III.
The department:
You will be joining 7 highly dedicated and skilled colleagues in the QA/RA department. You will become part of an ambitious team with an informal relation, good humour and where we take care of each other. We are open and honest and appreciate a colleague who takes responsibility and have a positive approach to new challenges.
The QA/RA department have close cooperation with different stakeholders. As UNEEG medical is a small company, the QA/RA department cover a broad range of tasks such as participating in development projects, maintaining and implementing new requirements in the quality management system, supporting manufacturing activities and market expansions.
Key responsibilities include:
- Ensure professional and proactive regulatory support in the development projects
- Define the regulatory strategy within development projects and change projects to ensure a fast-to-market approach.
- Submission of device files to authorities
- Maintaining and improving regulatory processes such as labelling requirements and UDI
- Conduct medical device intelligence review including monitoring of legislation and standards
Requirements:
- You have a Bachelor or a Master degree in relevant field of natural science, for example within biomedical engineering
- Minimum 2 years of experience in a regulatory position within medical devices - preferable you have been working with devices that contains electronics
- Experience with EU and US legislation for medical devices is required
- To succeed in the job, you are collaborative, have a structured approach, are proactive and have an eye for details while keeping the overview
- Given the international environment of UNEEG medical, English is our corporate language. You will use English in your daily work, which requires that you speak and write English at a high level.
About UNEEG medical A/S
UNEEG medical A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life. Our unique subcutaneous EEG solution for remote monitoring of brain activity was CE marked in 2019 and our continued international growth and technology roadmap ambitions will require several new functions and competencies in the years to come.
UNEEG medical A/S was founded in 2005. We currently employ approximately 100 people in Europe – the majority of these are situated in our new headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience. Read more about us at [email protected]
Information og data
Denne ledige stilling har jobtypen "Jurist", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 4.10.2021, 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.
- Jurist
- Kongens Lyngby
- Fredag den 05. november 2021
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Statistik over udbudte jurister i Kongens Lyngby over tid
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