Senior Risk Management Specialist
1 week ago
As a Senior Risk Management Specialist at LEO Pharma, you will be instrumental in safeguarding the quality and safety of our combination products. Your primary responsibility will involve overseeing our risk management protocols and human factors engineering processes tailored for LEO Pharma's drug-device combination offerings. Your proficiency in design control will be vital in supporting the safety of our marketed products.
Key Responsibilities:
- Formulate and execute risk management strategies in alignment with ISO14971 and ICHQ9 standards.
- Perform risk evaluations and analyses to pinpoint potential hazards and reduce risks associated with our drug-device combinations.
- Work collaboratively with multidisciplinary teams to weave usability and risk management practices throughout the product lifecycle.
- Offer guidance and assistance to product development teams in adopting risk management best practices and maintaining the product risk documentation.
- Conduct human factors engineering evaluations to confirm the usability and safety of our drug-device combinations in accordance with EU and US regulatory frameworks.
- Stay informed about industry regulations and standards pertinent to risk management and human factors engineering.
- Lead training initiatives on risk management for employees to bolster their understanding and awareness of risk management principles.
Qualifications:
To excel in this position, we anticipate 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 within the medical device sector.
- Comprehensive knowledge of ISO14971, ICHQ9, and ISO13485 standards and their application in risk management.
- A solid grasp of human factors engineering principles and their incorporation into product development.
- Experience in managing risks for combination products is highly advantageous.
- Excellent communication and interpersonal skills to effectively collaborate with multidisciplinary teams.
- Demonstrated ability to work autonomously and spearhead risk management initiatives.
Application Process:
For further details, please reach out to the appropriate contact within LEO Pharma. While a cover letter is not required, you are encouraged to include a brief statement in your resume or CV expressing your interest in this role.
About LEO Pharma:
LEO Pharma is a global leader in medical dermatology, committed to making a significant impact beyond the skin. Our innovative strategies distinguish us in the industry. We are dedicated to creating a legacy that positively influences patients, colleagues, and the environment. At LEO Pharma, we recognize the power of individuals to effect change. Our flat organizational structure allows you to make a tangible impact and provides diverse opportunities for professional development. We embrace diversity and welcome applications from all qualified candidates, understanding that varied perspectives and backgrounds enhance our decision-making process. Be part of our mission to make a difference.
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