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Regulatory Affairs Specialist, UK

Location: 

Peterborough, GB

Job Family:  Legal
Country/Region:  United Kingdom
 

About Coloplast

Coloplast develops products and services that make life easier for people with very personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this intimate healthcare. Our business includes Ostomy Care, Continence Care, Wound & Skin Care and Interventional Urology. We operate globally, and our organisation employs over 12,000 people.

 

Our culture

There is purpose to what we do. Most of us want to work for a company that makes a difference. Well, at Coloplast you can. We are ambitious, and we work together to achieve the best results. We work hard to provide a great service to our customers, but we are also focused on our people and what we can put in place to continue to make Coloplast a Great Place to Work. No matter where you work you will be in an environment that has a genuine family feel.

 

About you

Do you want to work for a market leading company that is driven by making a difference to people’s lives? Are you motivated to deliver a high professional service? If you are, then this opportunity will be of interest to you.

 

The role

The Regulatory Affairs (RA) Specialist for the UK Region ensures the regulatory compliance for the products marketed by Coloplast in the UK, whilst acting as trusted regulatory partner for the local commercial organisation. This notably entails:

 

  • Developing, implementing, and maintaining compliant, harmonised, best practice product registration and distribution activities for the UK Region
  • Staying abreast of new regulatory developments and providing regulatory expertise to the Global Regulatory Leads to accelerate market access and maintain products on the market
  • Ensuring timely local products registrations and acting as primary contact person with National Authorities for Coloplast’s UK Responsible Person

 

The position will report into the Head of Regulatory Affairs International (HQ in Denmark), with a dotted line to the UK Business Support Director. The position will be based in the UK Head Office and will be able to work flexibly between the office and home, in line with the local agreement.

 

The main responsibilities of the role are detailed below:

 

Acting as a Regulatory Affairs Country Liaison

  • Act as Country liaison for the HQ regulatory team
  • Subject Matter Expert on UK legislation
  • As appropriate, create local regulatory strategies for products in UK (both new products and updates to existing products
  • Ensure that the activities of Coloplast UK as UK Responsible Person are applied locally
  • Represent Coloplast for MHRA
  • Articulate regulatory requirements towards commercial stakeholders in the UK
  • Manage the MHRA national database and perform national registrations
  • Perform ad-promo reviews on marketing collaterals
  • Regulatory intelligence: capture, analyse, and share new & changing regulations with HQ
  • Assist in the application of Import/Export Licenses and Permits for applicable products
  • Obtain and provide required documentation and regulatory advice for Tenders.

 

Regulatory Operations & Compliance

  • Support to the Warehouse team on regulatory matters incumbent to distributors and importers
  • Support on traceability matters and fulfilment of distributor and importer duties, as applicable
  • Local quality system management support in relation to regulated activities
  • Support to the commercial organisation on ad-hoc questions relevant to regulatory matters
  • Support to the global regulatory process optimisation and other global assignments as appropriate
  • Ensure and maintain local and global instructions, supporting RA in the UK. 

 

The successful candidate will ideally have:

  • 3+ years of experience in regulatory affairs within medical devices or the healthcare sector
  • Ideally an educational qualification within engineering (STEM) or regulatory affairs
  • Fluency in English; both spoken and in writing
  • Knowledge of Microsoft Office will be an advantage.

 

You will also:

  • Aim high and want to be empowered
  • Like simplicity and yet understand a complex “medical mindset”
  • Have a strong focus on stakeholder management and a natural cultural awareness
  • Be comfortable reaching out to people and sparring with them on professional matters or conveying complicated issues in a way that can be understood by all parties
  • Have a dedication towards doing things right
  • Show a strong willingness to work with continuous improvement.

 

Need more information

For more information please visit our website at www.coloplast.co.uk/curious  Alternatively please email the Head of RA International, Eigil Ottesen-Hansen (dkeoh@coloplast.com).

 

Deadline

If you are interested in this position, please apply online by 3 June 2022.

 

Coloplast Limited is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, pregnancy or maternity.

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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 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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