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 eight-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 Regulatory Affairs Specialist II will work within the current regulatory environment and frameworks for all relevant markets that Aerogen wishes to market our products and to ensure in conjunction with the commercial requirements that all regulatory requirements for the individual markets are met and this involves a varied set of duties and responsibilities.
What are the key responsibilities? Commercial Strategy: Support global regulatory submission requirements, required for the continued growth of the Aerogen Ltd business.
Activities include:Understanding the regulatory requirements for the country in scope for a submission.Liaise with in-country regulatory partners to understand product specific submission requirements.Liaise with in-country regulatory partners to identify the documentation to support the submission requirements.Provide inputs to the commercial meetings ensuring our commercial partners are kept informed of regulatory changes and challenges for assigned countries and/or regions.Provide advice to our commercial partners.Ensure renewals are completed on time.Ensure authorized representatives are established where required and provide inputs to those agreements.Confidentially communicate with regulators and/or local agents regarding Aerogen submissions.Establish a project plan for the submission activity.Provide inputs to distributor and authorized representative agreements in line with the regulatory requirements.Liaise with the Aerogen commercial team to ensure the project deliverables and expected completion dates are clearly understood.Complete shipment controls via the Aerogen Ltd ERP system once products are approved or registrations expire.Escalate risks and issues as they arise during the planning and execution of activities.Support EMEA Commercial council Project QMS/RA.Involved in eQMS project.Integration Partners: Support registration activities for Integration Partners; new applications, renewals and regulatory queries.New Product Development: Support R&D, Operations and Manufacturing teams through the stage gates of new product development and sustaining changes.Compliance: Participate in regulatory authority audits as required.
Assist with CAPAs and non-conformances as required.Continuous Improvement: Identify and complete continuous improvement initiatives in the RA function.What education and experience are required? A minimum of a (Hons) degree in a Quality/Regulatory or related discipline.Minimum 3-5 years practical and relevant experience in Regulatory Affairs, medical device preferable.What key skills will make you great at the role? The person must be a "self-starter" in terms of time and task management and be able to operate with minimal supervision.Have a methodical review approach and be capable of initiating and leading change and continuous improvement.Ability to work within a team environment to achieve agreed company goals.Good understanding of ISO 13485, MDD, MDR and FDA QSR quality standards, MDSAP regional regulations.Proficiency in use of desktop software applications such as MS Office.Excellent verbal and written communication skills.Excellent attention to detail skills and strong in technical writing.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.Check out our careers website to discover more about Life at Aerogen.
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 ******.
Please include your name and preferred method of contact.
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