Device Risk Management Associate

Mylan Pharma Uk Ltd ,
Gloucester, Gloucestershire
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Overview

For Us, It’s A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you. Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help: · Develop an understanding of the proposed product, its marketed comparators, and the potential risks associated with design, manufacture and use of the product. · Conduct research to contribute to the Device Design and Development and Risk Management Plans. · Work within program teams to develop the user- and design-related Design Inputs and drive preliminary Risk Assessments. · Collaborate with Device Development colleagues, Clinicians and Pharmacovigilance teams to analyze, evaluate, mitigate and control risks at the user interface in line with international standards and our Quality Management System. · The Risk Management Associate will be monitoring, investigating and reporting through the risk management program design outputs such as formative usability outcomes and clinical complaints. Closely monitor the competitor landscape and provide a regular review of medical device reports and product recalls. · Support the delivery of design input documentation to meet the timelines of the stage-gate design review process and contribute to the resulting regulatory submissions, reporting the culmination of the device risk management program through the final risk benefit analysis. (For entry into Qualifications area) Make Our Values Your Values Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position: · Demonstrable experience of Risk Management in Medical Device or Pharmaceutical Industry. · Experienced in ISO and FDA regulations and standards as applicable to risk management. · Appropriate Science or Engineering Degree. · Excellent verbal and written communicator; clear and concise in communications with internal and external partners. · Regular travel between the Dublin, Cambridge (UK) and Sandwich (UK) sites averaging 20% of working year. · Occasional travel within Europe & US appropriate to project requirements, averaging 10% of working year. · Ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals. · Attention to detail in working approach. · Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the department. Why Mylan? If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care. Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran This job was originally posted as www.totaljobs.com/job/89733755

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