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 Senior Clinical Affairs Specialist is responsible for managing and executing Clinical Affairs activities that support Aerogen’s marketing, Medical Affairs and regulatory requirements throughout the development, approval and commercialisation of Aerogen devices. The role has a strong focus on generating, analysing and applying clinical data to demonstrate the benefits, safety and effective use of Aerogen devices and to support market access. 
Operating at specialist level, the role holder will independently manage allocated projects and provide Clinical Affairs expertise across cross-functional teams. The role holder will be recognised across the Medical, Clinical and Regulatory teams as a subject matter expert, with mentoring and development of less experienced team members forming a key part of the role. 

What are the key responsibilities? 
• Take ownership of clearly allocated Clinical Affairs portfolios and projects, working with the Clinical Affairs Manager to ensure proactive, end-to-end delivery of global clinical and post-market regulatory requirements, with priority given to FDA, MDD, MDR P1 and key P2 markets. This includes: 
• Designing, executing and maintaining pre-market and post-market clinical assessment strategies, using Aerogen’s Global Evidence Programme and, where required, additional clinical investigations and evidence-generation activities. 
• Preparing and maintaining Clinical Evaluation Plans and Reports (CEP/CER). 
• Developing and supporting Post-Market Clinical Follow-up (PMCF) plans and activities. 
• Providing Clinical Affairs contributions to Periodic Safety Update Reports (PSURs). 
• Supporting device safety vigilance and adverse event reporting. 
• Coordinating and consulting with expert external clinical stakeholders, including Key Opinion Leaders (KOLs). 
• Work closely with Medical Affairs and the Evidence Strategy and Operations Team to assess clinical needs and plan new evidence generation. Provide oversight of existing studies, assess new study proposals, contribute insight during and after study completion, and review and approve clinical study documentation in line with regulatory requirements and quality standards. 
• Work proactively with Marketing and R&D teams to develop clinical data strategies for new product development and product lifecycle programmes. 
• Support the Clinical Affairs Manager and work closely with Regulatory and Quality teams to coordinate effective clinical assessment and responses to complaints and adverse events. 
• Partner with Marketing and Medical Affairs to maximise the appropriate use of promotional claims, including the meta-analysis and publication of consolidated claims data. 
• Support the Medical Affairs team in maintaining the MA database for healthcare professional enquiries, including requests for off-label information and reports of safety or quality issues arising from general use or clinical trials. This includes: 
• Providing quarterly post-market surveillance reviews. 
• Ensuring that the latest clinical evidence is reflected in on-label and off-label Medical Information requests and responses. 
• Act as a subject matter expert in clinical evaluation and project management, including the formal mentoring of new Clinical Affairs specialist team members. 
• Contribute Clinical Affairs expertise, senior leadership and mentoring to the wider Medical Affairs team. 
• Act as a role model and actively reinforce Aerogen’s Culture and Values within and beyond the Medical Affairs team. 

What education and experience are required? 
• Bachelor’s degree in a relevant field such as biomedical engineering, life sciences, nursing or a related discipline. 
• Advanced degree, such as a Master’s or PhD, in an applicable field. 
• Previous experience in the medical device industry, specifically within Clinical Affairs. 
• Experience in the assessment, design and execution of clinical trials, and in applying and leveraging clinical trial data, is strongly preferred. 
• Experience in Medical Affairs or Regulatory Affairs, with a focus on PMS and PMCF, is preferred. 
• Medical or technical writing experience in the medical device industry, pharmaceutical industry or academia is essential. 
• Demonstrated experience interpreting clinical trial and other clinical data, including the application and analysis of biostatistics and statistical methodologies. 

What key skills will make you great at the role? 
• Excellent medical writing skills, with knowledge of ICMJE recommendations and the guidance and requirements applicable to documents supporting CE-marked medical devices, including CERs. 
• Knowledge of systematic literature review and meta-analysis processes, including biostatistics, with the ability to analyse and critically evaluate clinical data and consider the appropriate use of AI. 
• Strong attention to detail, logical thinking and the ability to interpret complex clinical data, identify patterns and solutions, and resolve issues in an organised and analytical manner. 
• Self-motivated and well organised, with the ability to work independently within a multidisciplinary team. 
• Ability to assess and organise personal workload and support others with prioritisation where required. 
• Knowledge of Good Clinical Practice (GCP) and other relevant regulatory requirements, including EU MDR. 
• Familiarity with medical terminology, anatomy and physiology. 
• Advanced proficiency in Microsoft Office, with a high level of computer literacy and experience using literature identification and review applications and websites. 
• Experience with, or knowledge of, regulatory submissions and approval requirements at the level expected of a senior specialist. 
• Certification to ISO 14155, or a medical writing qualification or relevant medical writing experience, would be beneficial. 
• Strong presentation, communication and influencing skills, with the judgement to adapt the message, format, length and pace to suit the audience. 
• Strong ability to collaborate effectively with cross-functional teams and external stakeholders. 
• Ability to act as a subject matter expert and mentor less experienced members of the Clinical Affairs team. 
• High personal and professional standards, with a commitment to personal development and continuous improvement. 
• Willingness to travel approximately 5–10% to engage with field-based teams, gather customer feedback, remain current with requirements, and network and assess best practice in clinical evaluation across the medical device industry. 

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.