Regulatory Affairs Specialist - maternity cover‎

Humlebæk, DK

Job Family:

Country/Region: Denmark

Would you like to work with products that improve the lives of people with intimate health care needs?

Join Coloplast and become part of a team of highly skilled RA specialists in Regulatory Affairs Wound and Skin Care, where we work with bringing new products to the market as well as doing life cycle management of marketed products.

Join a team of specialists in a global set-up
At our HQ in Humlebæk, you will join our Global Regulatory Affairs Wound and Skin Care team of 6 skilled RA specialists. Here, you will work with a wide variety of R&D and Lifecycle management projects across ostomy, continency, bowel management and skincare. The team is part of the Global Regulatory Affairs Group within Global Quality, Regulatory Affairs and Sustainability, which comprises colleagues from our subsidiaries and facilities all around the world.

”Coloplast is an innovative company and market leader within our Wound and Skin Care business. In Global RA we have open and relaxed culture and we continuously focus on having a strong and trustful team collaboration – we enjoy having open dialogues in the team and engage with many different stakeholders, ” says Adam Gregory Head of RA, Wound & Skin Care.

Play a key role in global innovation projects
Working with us, you can be sure that not two days will be the same. You will engage in cross-organisational project groups and collaborate with specialists in marketing, clinical operations, R&D, QA, RA specialists in US and China as well as with our subsidiaries and external partners and authorities.

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

• Be involved in developing and executing global regulatory strategies for new product introductions, maintenance of regulatory approvals and product changes, with direct responsibility for the EU and through alignment with international counterparts.
• Assess acceptability and state-of-the-art compliance of proposed labeling and technical/clinical documentation and write, review and maintain documentation to ensure that the technical file that supports our products is in compliance with the relevant regulatory requirements
• Represent RA for assigned projects/products by translating regulatory requirements into product requirements and participate in cross-functional groups dedicated to building knowledge across the organisation.

“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 Adam.

We are looking for a new colleague who enjoys communicating and collaborating across functions and cultures as part of a dynamic and interactive regulatory affairs 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 several projects at a time.

We expect that:

• 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 strong communication skills
• You speak and write English fluently

Interested?
If you would like to know more about the position, please call Adam Gregory, Head of RA, Wound & Skin Care on +45 49 11 14 01. 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 16.000 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.

Visit us on Coloplast.com.

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