12 month contract
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.

The Device Development Team in Mylan’s Global Respiratory Group is responsible for device design, industrialisation and analytical testing of new inhalation drug products. The team is part of Mylan’s Global R&D group.

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:

Main Accountabilities

Device Design and Development Program Schedule

• Build and maintain schedule of activities across device development group (DDG) which will deliver design and development activities in line with Design Control requirements.

• Working with DDG MT drive cross DDG activities against the program schedule ensuring that key deliverables are achievable and that all workstreams are aligned to timelines/priorities/component demands/reporting timelines.

• Through close collaboration with the project management team and manufacturing groups ensure DDG schedule aligned with other planning tools used across MGRG.

• Identify potential impacts of schedule changes and work with DDG MT to resolve issues with minimal impact to program.

Medical Device/Combination Product Technical Dossier Compilation

• Manage Design History File, ensuring contributors upload documentation appropriately and that regular reviews of DHF are conducted and actions are followed up.
• Coordinate DDG activities to support ANDA and MAA preparation.
• Deliver technical support to compilation of ANDA and MAA.




Skills and Experience

Essential

Demonstrable experience of:
• Leading medical device and/or drug/device combination programs in line with device design controls and ISO/FDA requirements as applicable to device design.
• Product development – concept to commercial
• Device development and manufacturing processes
• Analytical approach to problem solving

Education and Training

Essential

• Relevant Engineering/Science Degree

Other Requirements
Essential

• Excellent communicator; clear and concise in communications with internal and external partners.
• Ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals.
• Willingness to travel between the Dublin, Cambridge and Sandwich sites.
• 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?
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. 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. We encourage you to visit Mylan.com to learn more about our unconventional approach how your skills might complement our mission.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer. All information received will be handled carefully and treated with confidentiality.

To submit your application, please forward your CV and covering letter via the apply online button: