Regulatory Affairs Specialist
Location: Galway, Ireland
Sector: Medical Devices
About the Role
We are seeking a Regulatory Affairs Specialist to join a medical device organisation in Galway. This is an excellent opportunity for a regulatory professional with experience in medical devices, design assurance or a related technical field to contribute to product approvals, regulatory compliance and the ongoing commercialisation of medical devices across global markets.
The role will have a particular focus on US FDA regulatory submissions, alongside EU regulatory requirements, risk management and design assurance activities. You will work closely with cross-functional design and regulatory teams to ensure products meet the necessary regulatory and quality standards throughout their lifecycle.
Key Responsibilities
Develop and support global regulatory strategies for medical devices in collaboration with regulatory management.
Prepare and coordinate US FDA regulatory submissions, including 510(k), HDE, IDE and PMA applications.
Maintain a strong understanding of global medical device regulations, FDA guidance, EU requirements and applicable harmonised standards.
Liaise with regulatory authorities to support timely product approvals and maintain existing product registrations.
Support marketed products through regulatory change notifications, licence renewals and ongoing compliance activities.
Lead design reviews in accordance with internal procedures and applicable EU and FDA requirements.
Maintain Design History Files (DHF) and ensure accurate management of design quality records.
Lead risk management activities and prepare risk management documentation, including Design and Use FMEAs, in line with ISO 14971.
Collaborate with design teams to define product testing requirements and prepare design verification and validation plans, protocols and reports.
Support testing activities relating to sterilisation, biocompatibility, stability and transportation.
Ensure product quality standards and specifications align with relevant regulatory and company requirements.
Prepare standard checklists covering applicable harmonised standards and support the wider regulatory affairs function as required.
Skills, Qualifications & Experience
A minimum of one year of experience in Regulatory Affairs, Design Assurance or a similar role within the medical device industry.
A primary or postgraduate degree in Mechanical, Materials, Polymer or Biomedical Engineering, or another relevant technical discipline.
Knowledge and practical experience of risk management methodologies in accordance with EN ISO 14971.
Working knowledge of US FDA requirements, including 21 CFR 820, EU Medical Device Directive 93/42/EEC and applicable harmonised standards.
The ability to interpret and apply regulatory requirements in a practical medical device environment.
Previous experience preparing or supporting US FDA submissions is a distinct advantage.
Strong attention to detail and the ability to manage regulatory documentation and collaborate effectively with cross-functional teams.
Why Apply?
Opportunity to develop your regulatory affairs career within the medical device sector.
Exposure to US FDA submissions and international regulatory requirements.
Involvement in design assurance, risk management and product verification and validation.
The chance to work collaboratively with technical and regulatory teams across the medical device product lifecycle.
Interested in learning more?
If you have experience in medical device Regulatory Affairs or Design Assurance and are looking for your next opportunity, get in touch to discuss the role in confidence.
pbrowne@sigmar.ie
