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.
We are currently partnering with UNEEG medical. They are looking to recruit a Senior Regulatory Affairs Professional to join their internal team in greater Copenhagen, Denmark. The position is office based, full-time and some travel must be excepted.
As our new Senior RA Professional, you will be responsible for development and implementation on regulatory strategies providing regulatory input to R&D projects, and daily operation supporting our product portfolio that consist mainly of class III devices. UNEEG medical first product solution for monitoring and analyzing brain activity (EEG) aimed at improving the lives of fellow humans, impaired by epileptic seizures is available on the European market and you will have a key role supporting the market expansion, which includes US and rest of the world. In this position you will have a unique opportunity to influence the development of our processes within the regulatory department.
Key responsibilities include:
Requirements:
Why?
At UNEEG medical A/S we are looking for team members that thrive through an independent and ambitious work environment, where your curiosity, willingness to learn and a can-do attitude are used to benefit the team and reach our common goals
You will become part of an ambitious team with an informal tone, 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.
How?
For further information do reach out to Head of recruitment Ida Wenger- Parving on +45 2633 4301or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
We are currently partnering with UNEEG medical. They are looking to recruit a Senior Regulatory Affairs Professional to join their internal team in greater Copenhagen, Denmark. The position is office based, full-time and some travel must be excepted.
As our new Senior RA Professional, you will be responsible for development and implementation on regulatory strategies providing regulatory input to R&D projects, and daily operation supporting our product portfolio that consist mainly of class III devices. UNEEG medical first product solution for monitoring and analyzing brain activity (EEG) aimed at improving the lives of fellow humans, impaired by epileptic seizures is available on the European market and you will have a key role supporting the market expansion, which includes US and rest of the world. In this position you will have a unique opportunity to influence the development of our processes within the regulatory department.
Key responsibilities include:
- Develop and execute regulatory strategies for new and existing products to ensure a fast-to-market approach.
- Write and review documentation to ensure that the technical file supporting our products is in compliance with the relevant regulatory requirements.
- Prepare regulatory submissions for new and existing products
- Take part in ensuring that UNEEG medical successfully implements new EU and US medical device legislation by updating regulatory procedures and product documentation.
- Provide regulatory assistance and advice to sales and other stakeholders
- Contribute to the Medical Device intelligence review and monitoring
Requirements:
- In terms of education, you must hold either a bachelor’s or a Masters’ degree in the field of science.
- You have 5 or more years of experience in a global regulatory position within medical devices - preferable class III devices
- Experience in CE marking and US submission compilation for medical devices is essential. Preferably, you have working with devices containing software and electronics.
- You can find solutions by taking a deep dive into regulations and guidelines when needed.
- Experience with EU and US legislation for medical devices is required including ISO 13485 and 21 CFR 820.
- Pro-active and positive RA Professional with good communication skills
- Experience with regulatory writing is an advantance.
Why?
At UNEEG medical A/S we are looking for team members that thrive through an independent and ambitious work environment, where your curiosity, willingness to learn and a can-do attitude are used to benefit the team and reach our common goals
You will become part of an ambitious team with an informal tone, 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.
How?
For further information do reach out to Head of recruitment Ida Wenger- Parving on +45 2633 4301or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
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 25.6.2021, 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
- Mandag den 08. august 2022
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