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 The ideal candidate will possess: 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. #LGCIJ