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Head of Regulatory Affairs, Global Registrations & Regulatory Processes

Coloplast

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Would you like to lead an international team responsible for product regulatory approvals worldwide and enable our growth in emerging markets? Do you care for shaping and optimising processes, making it possible for a global regulatory department to always operate more efficiently?

This is your chance to work across geographies and cultures and gain a variety of inputs on global registrations and processes and use them to drive improvements for how we work even smarter to fulfill global regulatory compliance needs.

“As the company and the regulatory landscape keep evolving, we are also shaping our organisation to create the business of the future. This is a great time to join to help impact our 2025 ambitions, be an ambassador of regulatory culture and excellence in Coloplast – and ultimately, help make a difference to people with intimate health care needs,” explains Benjamin Rochette, Vice President, Global Regulatory Affairs.

Lead the Global Registrations & Processes team within Global Regulatory Affairs
You will join the Global Regulatory Affairs department with employees across Denmark, Poland, USA and China. Your team consists of 6 employees and 1 student assistant based in Humlebæk, closely collaborating with regulatory colleagues from our Business Center in Poland.

We are responsible for gaining international regulatory approvals for the entire Chronic Care and Wound & Skin Care portfolio of Coloplast, primarily focusing on emerging markets as we strive to achieve our market expansion objectives. Team members are responsible for navigating the regulatory landscape in their respective geographies while working closely with local offices to prepare and submit the regulatory applications and get new and modified products registered.

Part of the team is responsible for managing the processes that make it possible for our regulatory department to efficiently operate and fulfill the compliance requirements – notably regulatory information management, regulatory registration processes and regulatory intelligence.

Manage the international product registrations and regulatory processes
Being a global company operating in a regulated industry, Regulatory Affairs is a key enabler for Coloplast to achieve our objective and targets – strategic as well as operational. That is why we need you to manage the international product registration activities to expand and maintain the portfolio of regulatory licences within Chronic Care and Wound & Skin Care.

You will also be managing the regulatory processes and information systems that enable the Global Regulatory Affairs department to effectively conduct regulatory activities in compliance with applicable requirements from regulations, quality system and company policies.

While providing direction, leadership and coaching to your team members, you will:
• Drive and optimise the market expansion process, including defining, developing and reporting KPIs and providing transparent resource allocation
• Ensure coherent documentation packages for product approval aligned with business requirements for new/modified products for target geographies
• Develop, implement, optimise and maintain the regulatory processes and information systems that ensure compliance with applicable regulatory requirements, quality system and company policies
• Support quality system certification activities within areas of responsibility (e.g. MDSAP)
• Ensure global surveillance of new and changing regulations and their communication within Coloplast

Solid experience from the quality or QARA environment
“I envision a new colleague who is ready to challenge the status quo. Also, you have a strong methodological approach, think strategically and are able to work across multiple departments and cultures in Coloplast to create the right tools and processes that will allow for everyone to work smarter within the regulatory area,” says Benjamin.

Professionally, we imagine that you:
• Have solid experience in quality and/or regulatory affairs for medical devices with a solid general knowledge of regulatory requirements and design control activities
• Ideally have a few years of people management experience, but if you are the right profile, this could also be the next step in your career to a management position
• Have the ability to articulate regulatory requirements with business objectives, organise workflows and engage with IT specialists to develop effective solutions
• Are used to working across a matrixed and international organisation
• Are fluent in English

Interested?
If you would like to know more about the position, please call Benjamin Rochette, Vice President, Global Regulatory Affairs, on +45 4911 3101. 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 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.

Visit us on Coloplast.com.

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Coloplast - hurtigt overblik


Coloplast
Coloplast
Coloplast Danmark A/S markedsfører og sælger hjælpemidler i Danmark og i Island inden for stomi, kontinens, urologi samt hudpleje og sårbehandling.

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Holtedam 1
3050 Humlebæk
Logo: Coloplast
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