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Regulatory Affairs Specialist (12-month FTC), Ballina
Client:
LGC Group
Location:
Ballina, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
b39b0d88f47f
Job Views:
86
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
Company Description
Join Our Team as a Regulatory Affairs Specialist (1-Year Fixed Term Contract)
Are you ready to make a significant impact in the medical device industry?
We are seeking a dedicated Regulatory Affairs Specialist to join us on a 1-year fixed term contract. This role will be based in Ballina, Co. Tipperary, with flexibility for onsite presence 1-2 days per week.
If you are passionate about regulatory compliance and have a strong background in IVD and medical device industries, we want to hear from you.
Job Description
Technopath Clinical Diagnostics is a leading innovator in in vitro diagnostics, committed to delivering high-quality diagnostic solutions that improve patient outcomes globally. As we expand our product offerings and enter new markets, we need a skilled professional to ensure our products meet all regulatory requirements.
As our Regulatory Affairs Specialist, your primary responsibilities will include executing and leading CE marking activities, coordinating with Notified Bodies, and ensuring compliance with global regulatory standards.
You will play a crucial role in maintaining product registrations and submissions in regions including the US (FDA 510(k) process), Australia (TGA - The Therapeutic Goods Administration), Brazil (ANVISA), Canada (Health Canada), and Europe. Your expertise in launching new products and navigating conformity assessment processes will be invaluable as we continue to grow!
Qualifications
* Proven experience in regulatory affairs within the IVD and medical device industries.
* In-depth knowledge of global regulatory requirements, including FDA 510(k), TGA, ANVISA, and Health Canada.
* Experience working with Notified Bodies for CE marking conformity assessments.
* Ability to travel onsite to Ballina, Co. Tipperary, 1-2 days per week.
* Good communication skills, both verbal and written, with the ability to collaborate effectively across teams.
* Meticulous mentality with excellent interpersonal and prioritization skills.
* Minimum of degree qualification in relevant Science, Engineering, or Quality Assurance discipline.
Additional Information
Strong interpersonal skills and the ability to communicate well both verbally and in writing.
Excellent attention to detail and ability to prioritise.
Strong initiative and troubleshooting skills required.
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