IFU Co-ordinator

About Aerogen:
Headquartered in the vibrant city of Galway Ireland with offices around the world Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America collectively our employees make a difference to patients lives every day having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate challenge and test not only in relation to our products but every facet of how we work. We lead the way finding innovative solutions to even the most complex problems all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow our core culture of We Care universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter.

What is the role
The person in this role is responsible for the creation management and compliance of Instructions for Use (IFU) documents for medical devices. This role ensures that all IFUs meet regulatory requirements (e.g. MDR FDA) are user-friendly and accurately reflect the safe and effective use of the product. The coordinator works cross-functionally with User Experience Regulatory Quality Engineering Supply Chain Planning Graphic Design and Marketing teams to maintain high standards in product labeling and documentation.

What are the key responsibilities
Work with cross-functional teams to create and manage a process for IFU generation and updates
Coordinate the development review and approval of IFUs ensuring compliance with global regulatory and quality standards (FDA EU MDR ISO 15223 ISO 20417 etc.).
Manage content updates translations and version control for IFUs across multiple product lines and markets.
Support change control processes by preparing documentation routing approvals in eQMS and maintaining up-to-date IFU records.
Coordinate translations and localization of IFUs for international markets.
Work with R&D Quality and Clinical teams to gather technical content.
Collaborate with graphic designers and label engineers to ensure visual clarity and consistency
Support product launches and updates by delivering timely IFU revisions.
Conduct reviews and approvals of IFUs within the document control system.
Assist with the preparation of IFUs for regulatory submissions and audits.
Support the creating and maintaining of an eIFU system

What education and experience are required
Level 7 in STEM related field
3 years of experience in medical device documentation regulatory affairs or quality assurance.
Strong understanding of medical device regulations and standards.
Excellent written communication and technical writing skills.
Strong eye for design with a keen sense of aesthetics
Proven ability to create visually appealing and effective graphic layouts
Proficiency in document management systems and Microsoft Office Suite.
Ability to coordinate multiple projects simultaneously under tight timelines.
Experience with Adobe Creative Suite a plus.

What key skills will make you great at the role
Experience managing graphic projects and working with professional printers
Project Management experience
Change Management
Familiarity with eIFU platforms and digital labeling.
Experience managing translations liaising with external companies
Proof reading

What is it like to work in Aerogen
Our purpose is to transform patient lives and our ethos is to#discoverbetter. This also translates to how we look after our people. We want talented passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages and we are here to support our global team with a range of financial and non-financial rewards and benefits. Theres something for everyone! Here is an idea of what we offer:
Excellent medical care.
Bonus & Pension.
Aerogen Connect our employee led programme which supports our global teams to unite and have fun.
We pledge 1% of profits and time to charities and organisations.

Aerogen is committed to promoting diversity inclusion and equality in the workplace. If you have any difficulty using our application process please contact us by emailing emailprotected. Please include your name and preferred method of contact.