Regulatory Affairs Specialist for innovation projects

Would you like to help develop new products that will improve the lives of people with intimate health care needs?

Join Coloplast and become part of a team of highly skilled RA specialists that focus on bringing new products to the market.

Join a team of specialists in a global set-up
At our HQ in Humlebæk, you will join our Global Regulatory Affairs Innovation team of 9 skilled RA specialists. Here, you will work with a wide variety of R&D projects across ostomy, continency and wound care in lowest to highest risk classes. The team is part of the Global Regulatory Affairs Group within Global Quality, Regulatory Affairs and Sustainability, which comprises more than 150 colleagues around the world.

”Coloplast is an innovative company with a strong network and respect globally. In Global RA, we all enjoy a strong and trustful team culture – we support one another and use each other as professional sounding boards,” says Lykke Forchhammer, Director of RA Innovation.

Play a key role in global innovation projects
Working with us, you can be sure that no two days will be the same. You will engage in cross-organisational project groups and collaborate with specialists in marketing, clinical operations, R&D, RA specialists in US and China as well as with our subsidiaries and external partners and authorities.

Taking part in a variety of different R&D projects, you will:

• Be involved in developing and launching regulatory strategies 
• Write and review documentation to ensure that the technical file that supports our products is in compliance with the relevant regulatory requirements
• Participate in cross-functional groups dedicated to building knowledge across the organisation 
• Receive a thorough introduction to our product portfolio, and as a part of our development processes, you will have the opportunity to consult the end users of new products

“We are passionate about ensuring our products meet safety, efficacy and performance requirements because they make a real difference to the people who need them,” says Lykke.

Independent RA expert with a passion for regulations

• You bring minimum 2+ years’ experience with regulatory affairs – preferably from the MedTech industry or a related field
• You have in depth knowledge of regulatory legislation, standards and guidelines
• You have good medical writing skills 
• You speak and write English fluently
• Ideally, you have knowledge of requirements for software within the regulatory field

We are looking for a new colleague who enjoys communicating and collaborating across functions and cultures as part of a dynamic, interactive and innovative team. Your strong analytical skills enable you to digest large quantities of complex data while your keen eye for detail enables you to quickly spot potential challenges. Finally, your excellent planning skills allow you to juggle 1-3 projects at a time.

Interested? 
If you would like to know more about the position, please call Lykke Forchhammer, RA Innovation on +45 49 11 12 71. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.
 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 people and with products available in more than 143 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.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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