Design Control Specialist

Design Control Specialist

About the Role

Are you passionate about quality, innovation, and making a real difference in the medical device industry? Would you enjoy working in a collaborative, project-based environment working with Design Control and Risk Management activities?

We are looking for a Design Control Specialist to join our newly established team. In this vital role, you will drive the design control process and risk management activities, ensuring compliant, safe, and high-performing products that truly improve the lives of people with intimate healthcare needs.

You’ll work across disciplines, contribute to risk management activities, and help shape documentation during product lifecycle management.

Key Responsibilities

• Scope design change projects with product specialists and Regulatory Affairs.
• Drive Design Review activities
• Drive product risk management activities
• Ensure deliverables are in alignment with internal procedures and regulatory standards.
• Contribute to technical documentation (e.g. Risk Management File, User needs, Inputs, Outputs, Verification, Validation etc.).
• Collaborate with cross-functional teams across R&D, Regulatory Affairs, Medical Affairs, and Marketing etc..
• Take part in regular team discussions to align on subjective risk assessments and share best practices.

What We’re Looking For:

Education & Experience

•  Degree in Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or another Life Science field.
• Might have experience in the medical device or life sciences industry with a good understanding of design control and regulatory requirements.
• Background in product risk management, ideally in a regulated environment.

Skills & Competencies 

• Strong analytical and documentation skills – you enjoy working with detail and structure.
• Excellent communication skills in English, both written and verbal.
• Collaborative mindset – able to listen, engage with others, and build networks across teams.
• Curious and technically minded – eager to understand how products work and how to improve them.
• Proficiency in Microsoft Office.
• Business and value chain understanding
• Self-management and critical thinking
• Knowledge of:
• Quality Management Systems & Regulatory Standards (e.g. EN ISO 13485)
• Design Control
• Usability Engineering (IEC/EN 62366-1:2015/A1:2020)
• Risk Management (EN ISO 14971)

Ready to Make a Difference?

Become part of a purpose-driven company that values quality, collaboration, and continuous improvement. Join a dedicated team where your work truly matters – ensuring our products deliver maximum benefit with minimal risk to users.

Apply now to help shape innovative healthcare solutions that make lives better around the world.

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.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

59248
#LI-CO