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Risk Management Specialist
2 months ago
As a Risk Management Specialist at LEO Pharma, you will be instrumental in safeguarding the integrity and quality of our combination products. Your primary responsibility will involve overseeing our risk management protocols and human factors engineering processes for LEO Pharma's drug-device combination offerings. Your proficiency in design control will also be vital in supporting the safety of our marketed products.
More specifically, your responsibilities will encompass:
- Formulating and executing risk management strategies and frameworks in alignment with ISO14971 and ICHQ9 standards.
- Performing risk evaluations and analyses to pinpoint potential hazards and mitigate risks associated with our drug-device combination products.
- Collaborating with interdisciplinary teams to weave usability and risk management practices throughout the product lifecycle.
- Offering guidance and assistance to product development teams in adopting risk management best practices and maintaining the product risk documentation.
- Conducting human factors engineering evaluations to ensure the usability and safety of our drug-device combination products in accordance with EU and US regulatory standards.
- Keeping abreast of industry regulations and standards pertinent to risk management and human factors engineering.
- Leading risk management training initiatives for staff to enhance their comprehension and awareness of risk management principles.
Your Qualifications
To excel in this position, we envision that you possess the following qualifications:
- A Master's degree in a relevant scientific discipline (e.g., biology, chemistry, pharmacology) or engineering field, with an advanced degree preferred.
- A minimum of 3-5 years of experience in risk management for medical devices.
- Comprehensive knowledge of ISO14971, ICHQ9, and ISO13485 standards and their application in risk management processes.
- A solid understanding of human factors engineering principles and their integration into product development.
- Experience in managing risk for combination products is highly desirable.
- Excellent communication and interpersonal skills to effectively collaborate with interdisciplinary teams.
- Proven capability to work autonomously and lead risk management initiatives.
Your Application
You do not need to submit a cover letter, but you are welcome to include a few sentences in your resume or CV expressing your interest in this position.
Beyond the Skin
At LEO Pharma, a global leader in medical dermatology, we strive to make a lasting impact beyond the skin. Our innovative approach distinguishes us in the industry. We are committed to creating a legacy that positively influences patients, colleagues, and our planet.
We believe in the power of individuals to drive change. Our flat organizational structure allows you to make a significant impact and offers diverse roles for professional development. We value diversity and encourage applications from all qualified candidates, recognizing that our varied perspectives, backgrounds, and attitudes enable us to make the best decisions. Be yourself as we work together to make a difference.
Apply today and embark on our journey Beyond the Skin.
