Come Join Us
Position Risk Manager, Medical Device-User Interface
Location Sandwich, UK or Dublin, Ireland
Company Global Device Development
For Us, It’s A Mission
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership.
Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery of our large and growing range of generic and branded products around the globe. The technologies we develop enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and we work across Mylan to support innovative technology solutions to deliver healthcare to our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.
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.
An exciting opportunity has arisen within Mylans Global Device Development which is a diverse team of highly specialised engineers and scientists responsible for the design, industrialisation and testing of medical devices and drug delivery systems across Mylans global portfolio. Risk Management at the user interface is a key element in the development of our products.
Your role will be vital to the development program from concept through to regulatory submission and product lifecycle management. At the beginning of a development program, your role will be to contribute to the Device Design and Development and Risk Management Plans, develop the user-related Design Inputs and lead user-focussed Risk Assessments. Through your understanding of the intended use, foreseeable misuse and therapeutic benefit of the drug delivery device, medical device or medical technology you will collaborate with Human Factors Engineers, Design Engineers, Clinicians and Pharmacovigilance teams to analyse, evaluate, mitigate and control risks at the user interface in line with international standards and our Quality Management System.
The Risk Manager will be monitoring, investigating and reporting through the risk management program design outputs such as formative usability outcomes and clinical complaints. You will be closely monitoring the competitor landscape and will provide a regular review of medical device reports and product recalls.
You will be responsible for the delivery of design input documentation to meet the timelines of the stage-gate design review process and will be a key contributor to the resulting regulatory submissions, reporting the culmination of the device risk management program through the final risk benefit analysis.
We are looking for a candidate who is a Subject Matter Expert in the application of FDA and EU regulations and international standards related to Design Control, user interface and risk management. Who is interested in maintaining an awareness of the device development landscape and who has the technical drive and confidence to represent Mylan in the external environment.
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 now that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in healthcare. Here are the minimum qualifications for this position:
- Demonstrable experience of Risk Management and Design Controls (preferably in the area of user-focussed Risk Management) in Medical Device or Pharmaceutical Industry.
- Strategic thinking in the inter-relationship between user-focussed risk management and device design and development.
- Experienced in ISO and FDA regulations and standards as applicable to device design and 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.
If you want to be a 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 is an Equal Opportunity Employer.
To submit your application, please visit www.mylan.com/careers and select UK – you will then need to create a candidate profile to apply for the position. Requisition ID:
Closing date for applications: TBC