Posted 27 June, 2026
Clinical Affairs Specialist
Aerogen Ltd
Galway, Galway, Ireland
Full Time
Reference: 1401066348
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 an eleven-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.
Join us as we continue to #discoverbetter.
What is the role?
The Clinical Affairs Specialist will be responsible for managing and executing Clinical Affairs contribution to regulatory requirements to support the development, approval, and commercialization of Aerogen devices. In addition, you will utilise clinical data generation, data analysis to demonstrate the benefits of, and to ensure the safety and effective use of Aerogen devices, as well as market access of medical devices.
What are the key responsibilities?
• Lead post-market clinical follow-up activities (PMCF Plans, PMCF evaluation reports, contribution to PSURs, clinical assessments, complaints and vigilance activities.
• Develop key regulatory documents including clinical evaluation plans and clinical evaluation reports to support regulatory submissions in collaboration with QA/RA, DA, R&D etc.
• Management and development of clinical activities e.g. investigator-initiated studies, and clinical investigations.
• Collaborate with internal stakeholders, Marketing, Commercial, QARA, DA, R&D etc. to accomplish shared objectives.
• Cross-functional teamwork and collaboration to support the Medical Affairs team and Aerogen's strategic objectives.
What education and experience are required?
• Bachelor's degree in life science or other related discipline.
• Familiarity with requirements and regulations for clinical trials.
• Previous experience in the medical device industry, specifically Clinical Affairs, Medical Affairs or Regulatory Affairs with a focus on clinical evaluations/PMS/PMCF preferred.
• Medical or technical writing experience in medical device industry, pharmaceutical industry or academia.
• Experience in the interpretation of clinical data and application and analysis of statistics.
What key skills will make you great at the role?
• Masters or PhD in an applicable field ideally with a respiratory or cardiovascular disease/physiology focus.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• A logical thinker with the ability to analyse complex clinical data, interpret problems, and identify patterns and solutions.
• Self-motivated with the ability to work independently while collaborating within a multidisciplinary team.
• Ability to assess and organise workload, while taking a structured approach to managing it.
• Knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulatory guidelines like EU-MDR applicable to medical device industry.
• Excellent organisational abilities with a keen eye for detail.
What is it like to work at 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. 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 [email protected]. Please include your name and preferred method of contact.
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 an eleven-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.
Join us as we continue to #discoverbetter.
What is the role?
The Clinical Affairs Specialist will be responsible for managing and executing Clinical Affairs contribution to regulatory requirements to support the development, approval, and commercialization of Aerogen devices. In addition, you will utilise clinical data generation, data analysis to demonstrate the benefits of, and to ensure the safety and effective use of Aerogen devices, as well as market access of medical devices.
What are the key responsibilities?
• Lead post-market clinical follow-up activities (PMCF Plans, PMCF evaluation reports, contribution to PSURs, clinical assessments, complaints and vigilance activities.
• Develop key regulatory documents including clinical evaluation plans and clinical evaluation reports to support regulatory submissions in collaboration with QA/RA, DA, R&D etc.
• Management and development of clinical activities e.g. investigator-initiated studies, and clinical investigations.
• Collaborate with internal stakeholders, Marketing, Commercial, QARA, DA, R&D etc. to accomplish shared objectives.
• Cross-functional teamwork and collaboration to support the Medical Affairs team and Aerogen's strategic objectives.
What education and experience are required?
• Bachelor's degree in life science or other related discipline.
• Familiarity with requirements and regulations for clinical trials.
• Previous experience in the medical device industry, specifically Clinical Affairs, Medical Affairs or Regulatory Affairs with a focus on clinical evaluations/PMS/PMCF preferred.
• Medical or technical writing experience in medical device industry, pharmaceutical industry or academia.
• Experience in the interpretation of clinical data and application and analysis of statistics.
What key skills will make you great at the role?
• Masters or PhD in an applicable field ideally with a respiratory or cardiovascular disease/physiology focus.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• A logical thinker with the ability to analyse complex clinical data, interpret problems, and identify patterns and solutions.
• Self-motivated with the ability to work independently while collaborating within a multidisciplinary team.
• Ability to assess and organise workload, while taking a structured approach to managing it.
• Knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulatory guidelines like EU-MDR applicable to medical device industry.
• Excellent organisational abilities with a keen eye for detail.
What is it like to work at 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. 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 [email protected]. Please include your name and preferred method of contact.
