Risk Manager

Location: Ballerup 2750, Denmark, Denmark 
Contract type: Permanent 
Job ID: 2037 

NB: The location says Ballerup, Denmark, however job location could be all over Europe where LEO Pharma has affiliates.

Are you a highly motivated professional with a passion for ensuring safety in medicinal products? Are you ready to play a crucial role in product development and life cycle management activities for biologics? Then this is the perfect opportunity for you!

At LEO Pharma, our mission transcends the conventional. We are on an ambitious path to become the leaders in medical dermatology worldwide. We share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.

Your role

As a Risk Manager at LEO Pharma, you will play a crucial role in ensuring the safety and quality of our combination products. You will be responsible for managing our risk management processes and Human factors engineering process for LEO Pharma’s drug device combination products. Additionally, your expertise in design control will be essential in your support to ensuring the safety of our marketed products.

More in detail, your activities will include:

• Develop and implement risk management strategies and processes in compliance with ISO14971 and ICHQ9
• Conduct risk assessments and analysis to identify potential hazards and mitigate risks associated with our drug-device combination products
• Collaborate with cross-functional teams to integrate usability and risk management activities throughout the product lifecycle
• Provide guidance and support to product development teams in implementing risk management best practice and owning the product risk file
• Conduct human factors engineering assessments to ensure the usability and safety of our drug-device combination products in compliance with EU and US regulatory requirements
• Stay up-to-date with industry regulations and standards related to risk management and human factors engineering
• Lead risk management training programs for employees to enhance their understanding and awareness of risk management principles

Your qualifications

To succeed in this role, we imagine that you have the following qualifications:

• Masters's degree in a relevant scientific discipline (e.g., biology, chemistry, pharmacology) or engineering field. Advanced degree preferred
• Minimum of 3-5 years of experience in risk management of medical devices
• In-depth knowledge of ISO14971, ICHQ9 and ISO13485 standards and their application in risk management processes
• Strong understanding of human factors engineering principles and their integration into product development
• Experience in managing risk for combination products is highly desirable
• Strong communication and interpersonal skills to effectively collaborate with cross-functional teams
• Proven ability to work independently and lead risk management initiatives

Your application

For additional information, please contact Frédéric Osuch, Director for Drug-Device Combination Products, +4531206721.

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.
 
For certain positions, LEO Pharma might complete a background check conducted by a third party.

Join us on our journey Beyond the Skin. Apply today!