Title: Regulatory Specialist
Location: Galway business park, Galway
Benefits: Salary, bonus, pension, hybrid working and healthcare

Overview:
As a Regulatory Specialist you will support the commercialisation of Medical Device products. This includes preparation and submission of regulatory filings for product market entry, as well as regulatory activities required for the maintenance of existing commercial products. The position requires a high level of innovative thought and problem-solving skills. In order to coordinate the variety of regulatory related tasks, the role requires a high degree of flexibility, and structured time and task management


Responsibilities:
- Contribute to the preparation, review and filing of 510(k) submissions to the FDA for both pre-commercial and commercial products
- Prepare and coordinate CE mark submissions/change notifications and Notified Body interactions.
- Maintain Technical Documentation according to the requirements of the Medical Device Regulation.
- Submit and maintain filings on US and EU regulatory databases (eg FURLS, EUDAMED)
- Provide input to the Change Control process for design, manufacturing, and specification changes to assess impact on regulatory compliance and requirements.
- Assist in the development and maintenance of device labelling and IFUs to help ensure they comply with regional regulatory requirements
- Represent Regulatory Affairs within project teams to provide direction.
- Provide regulatory input to customer complaint investigations.
- Support post-market surveillance and vigilance activities, including submission of adverse event reports.


Requirements:

• Degree in Engineering or Science discipline
• Minimum of 2 years’ experience in the medical device industry
• Understanding of FDA and/or MDR requirements, with the ability to interpret and implement these requirements
• Strong technical aptitude with an ability to analyse and challenge data, identify and address gaps, and generate technical reports to support submissions
• Self-motivated and clear minded approach to regulatory activities