Regulatory Affairs Manager
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Humlebæk
Join us to become part of a global company that makes a difference every day.
We are looking for a Regulatory Affairs Manager to join our Global Regulatory Affairs Operations team. You will be part of a team of 12 specialists supporting the global lifecycle management of a very diverse product portfolio of medical devices from the lowest to the highest risk class. You will join us at an exciting time, where product regulations and demands are changing.
Expected start date is as soon as possible. And when you start, you can be sure to get a thorough introduction to Coloplast, our products and the way we work with regulatory affairs.
“You will get a broad network, collaborating with other specialists and our subsidiaries, and get your hands on diverse projects. By doing so, you make sure our products reach end-users, who need them to alleviate their intimate health care needs” says Joan Drejer, Global RA Director.
Collaborating across functions and cultures
The team is part of the Global Quality & Regulatory Affairs organisation.You will become an expert on one of our product groups, e.g. Ostomy Care, Continence Care or Wound Care and you will be involved in change projects where you use your regulatory knowledge to evaluate and communicate the impact of changes to product components on documentation and existing and ongoing product registrations globally.
As we work in cross-organisational project groups, you will collaborate with specialists in Quality, Marketing, Clinical operations, Supply chain and R&D as well as with our subsidiaries and external partners and authorities. To do so, you need to be comfortable communicating, coordinating and collaborating across functions and cultures, applying your proactive mindset to plan, execute and meet deadlines.
Working with multiple projects, you will participate in writing and reviewing documentation to ensure that the technical file that supports our products is in compliance with the relevant regulatory requirements. You will:
Analytical and collaborative with knowledge of the medtech industry
Our backgrounds are varied, but you are familiar with the medtech industry – e.g. engineers, pharmacists, biologists or nurses.
Also, we imagine you:
Interested?
At Coloplast we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
For more information, please contact Director, RA and Biosafety, Joan Drejer on e-mail [email protected]. Please apply by uploading your CV and Cover Letter in English. Make sure that you highlight how your past experience is relevant for this role and what your motivation is for applying. We will start to take candidates into the recruitment process in January and will do so continuously. We will close the position down, once we have found the right candidate.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
We are looking for a Regulatory Affairs Manager to join our Global Regulatory Affairs Operations team. You will be part of a team of 12 specialists supporting the global lifecycle management of a very diverse product portfolio of medical devices from the lowest to the highest risk class. You will join us at an exciting time, where product regulations and demands are changing.
Expected start date is as soon as possible. And when you start, you can be sure to get a thorough introduction to Coloplast, our products and the way we work with regulatory affairs.
“You will get a broad network, collaborating with other specialists and our subsidiaries, and get your hands on diverse projects. By doing so, you make sure our products reach end-users, who need them to alleviate their intimate health care needs” says Joan Drejer, Global RA Director.
Collaborating across functions and cultures
The team is part of the Global Quality & Regulatory Affairs organisation.You will become an expert on one of our product groups, e.g. Ostomy Care, Continence Care or Wound Care and you will be involved in change projects where you use your regulatory knowledge to evaluate and communicate the impact of changes to product components on documentation and existing and ongoing product registrations globally.
As we work in cross-organisational project groups, you will collaborate with specialists in Quality, Marketing, Clinical operations, Supply chain and R&D as well as with our subsidiaries and external partners and authorities. To do so, you need to be comfortable communicating, coordinating and collaborating across functions and cultures, applying your proactive mindset to plan, execute and meet deadlines.
Working with multiple projects, you will participate in writing and reviewing documentation to ensure that the technical file that supports our products is in compliance with the relevant regulatory requirements. You will:
- Participate in cross-functional projects for product modifications to ensure regulatory compliance
- Prepare regulatory files, clarify procedures and create or approve relevant documentation
- Communicate regulatory requirements across Coloplast
- Document design and process changes including review of technical documentation
- Review and approve instructions for use, labels and marketing material
- Develop and maintain procedures and instructions
Analytical and collaborative with knowledge of the medtech industry
Our backgrounds are varied, but you are familiar with the medtech industry – e.g. engineers, pharmacists, biologists or nurses.
Also, we imagine you:
- Are familiar with directives, standards and guidelines
- Preferably have experience within regulatory affairs
- Are detail-oriented, analytical and capable of digesting large amounts of complex data
- Speak and write English fluently
Interested?
At Coloplast we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
For more information, please contact Director, RA and Biosafety, Joan Drejer on e-mail [email protected]. Please apply by uploading your CV and Cover Letter in English. Make sure that you highlight how your past experience is relevant for this role and what your motivation is for applying. We will start to take candidates into the recruitment process in January and will do so continuously. We will close the position down, once we have found the right candidate.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
Information og data
Denne ledige stilling har jobtypen "Jurist", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Humlebæk.
Jobbet er oprettet på vores service den 4.1.2020, 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.
- Jurist
- Humlebæk
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