Regulatory Affairs Specialist Location: Hybrid (Remote & Ballina, Tipperary)

As a Regulatory Affairs Specialist at Technopath, you'll play a key role in ensuring compliance with regulatory requirements for our medical devices. Working from home and at our Ballina, Tipperary location, you'll be responsible for executing tasks related to CE marking, maintaining product registration and notifications, and preparing regulatory submissions.

Your responsibilities will include:

• Reviewing and maintaining a list of current standards and regulations
• Providing regulatory input and approval for new products and changes
• Maintaining and organizing regulatory records to demonstrate compliance with applicable regulations
• Communicating with regulatory authorities as needed
• Providing support to Quality Assurance, R&D Quality, and Quality Systems teams from a regulatory perspective
• Ensuring compliance with all documented Quality System requirements and regulations in markets where Technopath distributes

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To be successful in this role, you should have a minimum of a bachelor's degree in a science, engineering, or quality assurance discipline and at least 3 years of experience working in a regulated medical device or in vitro medical device environment. You should also have thorough knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC and IVDR 2017/746, and be familiar with ISO 14971. Strong interpersonal skills and the ability to communicate well both verbally and in writing are essential, as is excellent attention to detail and the ability to prioritize.

Join our team and make a difference as a Regulatory Affairs Specialist at Technopath.