Offer summary
Qualifications:
Proven experience in IVD and medical device industries, Knowledge of global regulatory requirements like FDA 510(k), TGA, ANVISA, Health Canada, Experience with CE marking conformity assessments, Ability to travel to Ballina, Co. Tipperary 1-2 days per week, Degree in Science, Engineering, or Quality Assurance.
Key responsabilities:
- Execute and lead CE marking activities
- Coordinate with Notified Bodies
- Ensure compliance with global regulatory standards
- Maintain product registrations
- Submit products in multiple regions