Job Opportunity
We are seeking an experienced professional to lead our regulatory affairs strategy.
* Develop and drive global regulatory strategies for medical device products.
* Manage all regulatory submissions (CE marking, FDA 510(k)/PMA) with precision and timeliness.
* Represent the company in regulatory interactions and negotiations, fostering strong relationships and strategic partnerships.
Key Requirements:
* 10+ years of experience in Regulatory Affairs within the medical device industry, with a proven track record of success.
* Leadership role with expertise in preparing and leading regulatory submissions for Class II/III devices, driving business growth and expansion.
* Strong understanding of the global regulatory environment, with the ability to navigate complex regulations and policies.
About the Company:
A dynamic medical device start-up based in Galway, committed to innovation and excellence.
What We Offer:
* Competitive compensation package
* Equity participation
* Attractive benefits and rewards