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, including being named Galway Chamber Company of the Year 2025, and twelve-time winner of the Zenith Award for Respiratory Care Excellence in North America, our employees make a difference to patients’ lives every day, having reached over 30 million patients in more than 80 countries.

Today, Aerogen is powered by a global team representing 54 nationalities, working together with a shared commitment to improving patient care. 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 by finding innovative solutions to even the most complex problems, all in the name of delivering better patient outcomes.

Our business continues to grow 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.

What is the role?  
The person in this role is responsible for Document Control System administration & management through processing of required changes as per the current system. Co-ordination of workflow & prioritization including capture of relevant metrics.

What are the key responsibilities?  
Document Management
• Help maintain the organization's document control system and ensure all controlled documents are accurately recorded.
• Manage document creation, review, approval, revision, distribution, and archival processes.
• Ensure only current approved versions of documents are available for use.
• Maintain indexing, filing, and retrieval systems.
• Facilitate document updates and revisions with document owners and departmental stakeholders.
• Archive obsolete documents in accordance with retention requirements.

Quality & Compliance
• Ensure document control activities comply with applicable regulatory and quality standards (e.g., ISO 13485, MDSAP, MDR, QMSR, and all relevant local Regulations).
• Support internal and external audits by providing documentation and records as required.
• Monitor document review schedules and facilitate the periodic reviews process.
• Assist with change control processes associated with quality management systems.

Systems Administration
• Maintain quality management systems (QMS) and document repositories.
• Upload, scan, organize, and maintain electronic and hard-copy records.
• Generate reports and document status metrics as required.
• Manage document access permissions and security controls where applicable

Stakeholder Support
• Provide guidance and training to employees regarding document control procedures.
• Liaise with Quality, Regulatory, Engineering, Operations, and other departments regarding documentation requirements.
• Support continuous improvement initiatives relating to document management processes.
• Respond to requests for controlled documents and records in a timely manner.
• Complete any other activities as required

What education and experience are required? 
• Diploma or Bachelor's Degree in Business Administration, Quality, Information Management, or related discipline.
• 2+ years' experience in a document control, quality administration, or records management role.
• Experience working with document management systems and Microsoft Office applications.
• Strong understanding of document control principles (ALCOA++), version control, and records management.
• A good understanding of EN ISO 13485, MDSAP, MDR, QMSR requirements.

What key skills will make you great at the role?
• Strong administrative and organisational skills
• Excellent attention to detail
• Ability to manage multiple priorities
• Effective verbal and written communication
• Maintaining Confidentiality and discretion
• Problem-solving capability
• Ability to work independently and collaboratively
• Continuous improvement mindset

What is it like to work at Aerogen?  
Our purpose is to transform patients' lives and innovation is embedded in our culture. 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. There’s 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 careers@aerogen.com. Please include your name and preferred method of contact.